Substrates P400 en

ABX Pentra
Albumin CP
ABX Pentra Albumin CP

Ref.: A11A01664
Volume: 99 ml
Diagnostic reagent for quantitative in-vitro

determination of Albumin in serum and
plasma by colorimetry.
2009/09/28
A93A00102J EN
A11A01664
99 ml
Clinical Interest
Albumin is the main component of plasmatic proteins. Its essential
role is the maintenance of osmotic pressure. It also assures the
fixation and transport of a large number of products. The albumin
serum constitutes a predictive factor in the alteration of the transport
of bilirubine, calcium and hormones due to a deteriorated functioning
of the liver and/or due to inflammations. A relative increase of
plasmatic albumin is observed in states of dehydration. The decreases
are the result of malnutrition, synthesis alteration (hepatic
pathologies) or a serious loss of albumin by the organism (traumas,
burns, haemorrhages, diarrhoea, nephrotic syndromes and cancers).
Method
Colorimetric determination using bromocresol green (BCG).
At pH 4.2 the bromocresol green fixes itself selectively to albumin,
colouring it blue.
HORIBA ABX SAS

BP 7290
34184 Montpellier - cedex 4 - France
The frequency of controls and the confidence intervals should

correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
exceed these confidence limits.
Reagents
ABX Pentra Albumin CP is ready-to-use.
Reagent: Succinate acid
58 mmol/l
Azid, Succinate acid, 6 H2O 29 mmol/l
Bromocresol green
0.14 g/l
Brij 35
7 ml/l
ABX Pentra Albumin CP should be used according to this reagent
notice. The manufacturer cannot guarantee its performance if used
otherwise.
Handling
Remove the cap of the cassette, place in the refrigerated ABX Pentra
400 reagent compartment.
If present, remove foam by using a plastic pipette.
Automated clinical chemistry analyser

Standard laboratory equipment
Specimen
Serum
Plasma in heparin
Reference range(10)
Ambulatory patients:
Stationary patients:
38
3.8
35
3.5
55 g/l
5.5 g/dl
52 g/l
5.2 g/dl
Calibrator
We recommended that each laboratory establishes its own reference

range.
For calibration, use:

ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
Storage and Stability
Control
Form-0846 Rev. 3
Materials required but not provided
For internal quality control, use:

ABX Pentra N Control, Ref. A11A01653 (not included)
ABX Pentra P Control, Ref. A11A01654 (not included)
Each control should be assayed daily and/or after each calibration.
Reagents, in unopened cassettes, are stable up to the expiry date on

the label if stored at 2-8 C and protected from light.
Stability after opening: refer to the paragraph "Performance on ABX
Pentra 400".
Assay Procedure
Test instructions for other automated systems than ABX Pentra 400 are
available on request.
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B
Latest version documents on www.horiba.com
ABX Pentra
Albumin CP
Waste Management
Please refer to local legal requirements.
General Precautions
1. Reagent, for professional in-vitro diagnostic use only.
2. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
3. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400

The performance data listed below have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 327 tests.
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated ABX
Pentra 400 compartment is stable for 83 days.
Sample volume: 2 l/test
Detection limit:
The detection limit is determined according to the Valtec protocol (6)
and equals 2.9 mol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (6).
Normal control
Pathological control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

514
506
349
629
848
CV %
0.6
0.8
0.4
0.5
0.8
Reproducibility (run-to-run precision)

2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (7).
Normal control
Specimen 1
Specimen 2
Mean value mol/l

515
502
357
643
CV %
1.26
0.95
1.66
1.85
Linearity and Measuring Range:

The reagent linearity is determined according to the recommendations
found in the NCCLS, EP6-P protocol (8).
Low linearity: 2.9 mol/l
High linearity: 909 mol/l, with automatic post-dilution: 1818 mol/l.
Correlation:
59 patient samples are correlated with a commercial reagent taken as
reference according to the recommendations found in the NCCLS, EP9A2 protocol (9).
The equation for the allometric line obtained is:
Y = 0.95 x + 22 with a correlation coefficient r = 0.992.
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:
No significant influence is observed up to 232 mol/l

No significant influence is observed up to 7 mmol/l
Conversion factora:
mol/l x 0.066 = g/l
mol/l x 0.0066 = g/dl
Calibration stabilityb:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 14 days.
Note: A recalibration is recommended when reagent lots change, and
when quality control results fall outside the range established.
Application release: 4.xx
Warning
It is the user's responsibility to verify that this document is applicable
to the reagent used.
Reference
1. Doumas B. et al., Watson. W, Ard and Biggs H.G. Albumin
standards and the measurement of serum albmin with bromocresol
green, Clin. Chim. Acta, 31, (1971), 87.
2. Doumas B. T. and Biggs H.G., Determination of serum albumin
Standard Methods of Clinical Chemistry, Acad. Press N.Y., 7,
(1972), 175.
3. Drupt F., Dosage de lalbumine srique par le vert de bromocrsol
Pharm. Biol., 9, (1974), 777.
4. Metais P. Biochimie Clinique. Tome 3: Biochimie fonctionnelle:
Srum Albumine. Paris: Simep; 1988:107.
5. Doumas BT., PETERS T Jr. - Serum and urine albumin albumin: a
progress report on their measurement and clinical significance.
Clin. Chim. Acta., 258 (1), (1997), 3-20.
6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
7. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
a. Modification from index I to J: correction of conversion factor.

b. Modification from index I to J: modification of calibration stability.
ABX Pentra
Albumin CP
8. Evaluation of the Linearity of Quantitative Analytical Methods,

Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
9. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nd ed., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.
10. Johnson, A.M., Rohlfs, E.M., Silverman, L.M., Proteins, Tietz
Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A., Ashwood,
E.R., (W.B. Saunders eds. Philadelphia USA), (2001), 325.
ABX Pentra
Albumin CP
ABX Pentra
Bilirubin, Direct CP
ABX Pentra Bilirubin, Direct CP

Ref.: A11A01635
Volume R1: 24 ml
Volume R2: 7 ml

determination of direct Bilirubin in serum
and plasma.
2007/08/27
A93A00122H EN
A11A01635
24 ml
7 ml
Clinical Interest (1,2)

Bilirubin is a breakdown product of hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water, thus
forming a complex with albumin for the transport in the blood from
the spleen to the liver. In the liver, bilirubin is conjugated with
glucoronic acid and the resulting water soluble bilirubin glucoronic
acid is excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin production due
to hemolysis (pre-hepatic jaundice), by parenchymal damages of the
liver (intra-hepatic jaundice) or by occlusion of bile ducts (post-hepatic
jaundice). A chronic congenital (predominantly unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in the
population. High levels of total bilirubin are observed in 60-70% of
neonates due to an increased postpartal breakdown of erythrocytes and
because of delayed function of enzymes for bilirubin degradation.
Common bilirubin methods detect either total bilirubin or direct
bilirubin. Determinations of direct bilirubin measure mainly conjugated,
water soluble bilirubin. Unconjugated bilirubin can therefore be
estimated as the difference between total bilirubin and direct bilirubin.
Method
Photometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a
red colored azocompound in acidic solution.
Reagents
ABX Pentra Bilirubin, Direct CP is ready-to-use.
Reagent 1: EDTA-Na2
0.1 mmol/l
NaCl
9 g/l
Sulfamic acid
100 mmol/l
Reagent 2: 2,4-Dichlorophenyl-diazonium salt 0.5 mmol/l
HCl
700 mmol/l
EDTA-Na2
0.13 mmol/l
ABX Pentra Bilirubin, Direct CP should be used according to this
reagent notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
Form-0846 Rev. 2
Handlinga
Remove both caps of the cassette. If present, remove foam by using a
plastic pipette.
Position the respective protective cap, ref. GBM0969 on R1 and Ref.
GBM0970 on R2 and place in the refrigerated ABX Pentra 400 reagent
compartment.
HORIBA ABX
BP 7290
34184 Montpellier- cedex 4 - France
Calibrator
Control

NaCl solution: 9 g/l
Standard laboratory equipment.
Specimen
Serum.
Heparin Plasma.
It is very important to store the sample protected from light.
Stability: 2 days
at 15 - 25 C
7 days
at
2 - 8 C
3 months at
- 20 C in case of immediate freezing.
Freeze only once.
a. Modification from index G to H: new handling.
Latest version documents on www.horiba-abx.com
ABX Pentra
Reference range (1)

Adults and children: 0 - 0.2 mg/dl (0 - 3.4 mol/l).

the label if stored at 2 - 8 C protected from light and contamination
is avoided.
Stability after opening : refer to the paragraph Performance on ABX
Pentra 400.
Do not freeze the reagents.
Assay Procedure
Waste Management
General Precautions
1. This reagent is for professional in-vitro diagnostic use only.
2. Take the necessary precautions for the use of laboratory reagents.

Normal control
Specimen 1
Specimen 2
CV %
4.26
4.22
3.27
2.98

Correlation:
Y = 0.92 x + 0.58 with a correlation coefficient r2 = 0.9899.
Interferences:
Haemoglobin:
Triglycerides:
Mean value mol/l

16.0
34.6
11.7
65.4
Do not use haemolysed samples.

No significant influence is observed up to 7 mmol/l.
Number of tests: 100 tests
Conversion factor:
mol/l x 0.584 = mg/l
mol/l x 0.0584 = mg/dl
On board Reagent Stabilitya:

Calibration stabilityb:
Detection limit:
protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

15.3
31.6
4.0
25.9
134.6
CV %
0.67
0.44
3.23
0.59
2.69
a. Modification from index G to H: new on board reagent stability.

Application releasec: 3.xx
Warning
It is the users responsibility to verify that this document is applicable
Reference
1. Thomas L. ed. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
TH-Books Verlagsgesellschaft, 1998; 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia:
W.B Saunders Company; 1999. p. 1125-1177.
b. Modification from index G to H: modification of calibration stability.
c. Modification from index F to G: suppression of minor index.
ABX Pentra
3. Rand R.N., di Pasqua A. A new diazo method for the determination

of bilirubin. Clin. Chem. 1962; 6:570-8.
february 1999.
september 1986.
19, 2002.
ABX Pentra
ABX Pentra
ABX Pentra Bilirubin, Total CP

Ref.: A11A01639
Volume R1: 44 ml
Volume R2: 14 ml
Bilirubin, Total CP
Intended Use
2009/10/21
A93A00112O EN

determination of total Bilirubin in serum and plasma
of adults and neonates.
A11A01639
44 ml
14 ml

Bilirubin is a breakdown product of hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water, thus
forming a complex with albumin for the transport in the blood from
the spleen to the liver. In the liver, bilirubin is conjugated with
glucoronic acid and the resulting water soluble bilirubin glucoronides
are excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin production
due to hemolysis (pre-hepatic jaundice), by parenchymal damages of
the liver (intra-hepatic jaundice) or by occlusion of bile ducts (posthepatic jaundice). A chronic congenital (predominantly unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in the
population. High levels of total bilirubin are observed in 60-70% of
neonates due to an increased postpartal breakdown of erythrocytes
and because of delayed function of enzymes for bilirubin degradation.
Common bilirubin methods detect either total bilirubin or direct
bilirubin. Determinations of direct bilirubin measure mainly
conjugated, water soluble bilirubin. Unconjugated bilirubin can
therefore be estimated as the difference between total bilirubin and
direct bilirubin.
Method (3)
Photometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a
red colored azocompound in acidic solution. A specific mixture of
detergents enables a safe determination of the total bilirubin.
Reagents
ABX Pentra Bilirubin, Total CP is ready-to-use.
Reagent 1: Phosphate buffer
50 mmol/l
NaCl
9 g/l
Detergent, stabilizers
Reagent 2: 2,4-Dichlorophenyl-diazonium salt
5 mmol/l
HCl
130 mmol/l
Detergent
ABX Pentra Bilirubin, Total CP should be used according to this
reagent notice. The manufacturer cannot guarantee its performance if
used otherwise.
HORIBA ABX SAS

BP 7290
Calibrator
Control

Automated clinical chemistry analyser: ABX PENTRA 400
Calibrator: ABX Pentra Multical, Ref. A11A01652
Controls: ABX Pentra N Control, Ref. A11A01653, and
ABX Pentra P Control, Ref. A11A01654
NaCl solution 9 g/l
Specimen
Form-0846 Rev. 2
Handling
Remove both caps of the cassette, place in the refrigerated ABX Pentra
Serum.
Plasma in lithium heparin.
ABX Pentra
Bilirubin, Total CP

Stability (1,10):
1 day at 20-25C
7 days at 4-8C
6 months at -20C
It is very important to store the sample protected from light!

In the case of intensive sun irradiation: decrease in total bilirubin by
up to 30% after 1 hour.
Reference range (1)

Each laboratory should establish its own reference ranges. The values
given here are used as guidelines only.
Neonates:
24 hours:
2nd day:
3rd day:
4th - 6th day:
Adults:
mg/dl
mol/l
< 8.7
1.3 - 11.3
0.7 - 12.7
0.1 - 12.6
0.1 - 1.2
< 150
22 - 193
12 - 217
2 - 216
2 - 21

the label if stored at 2 - 8 C and contamination is avoided.
Pentra 400.
Limits:
Limit of blank:
The limit of blank is determined according to CLSI (NCCLS), EP17-A
protocol (8) and equals 1.09 mol/l.
Limit of detection:
The detection limit is determined according to CLSI (NCCLS), EP17-A
protocol (8) and equals 1.49 mol/l.
Limit of quantitation:
The limit of quantitation is determined according to CLSI (NCCLS),
EP17-A protocol (8) and equals 2.4 mol/l.
4 specimens of very low, low, medium and high concentration and 2
controls are tested 20 times according to the recommendations found
in the Valtec protocol (4).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Specimen 4
Mean value mol/l

16.59
87.61
10.34
14.57
37.65
142.82
CV %
2.14
0.99
3.09
2.23
1.33
0.83
Assay Procedure
available on request (not available in the USA).
Waste Management
Reproducibility (total precision)

3 specimens of low, medium and high levels and 2 controls are tested
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol (5).
General Precautions

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

17
94
13.62
48.96
156.13
CV %
4.04
1.70
5.97
2.78
2.20
Measuring Range:
The assay confirmed a measuring range in serum and plasma from 2.4
to 450.0 mol/l, providing an upper linearity of 450.0 mol/l, with an
automatic post-dilution up to 1350 mol/l.
found in the CLSI (NCCLS), EP6-A protocol (6)
Correlation (adult samples):
101 patient samples (serum) are correlated with a commercial reagent
taken as reference according to the recommendations found in the
CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 5.6 to 441.8
mol/l.
ABX Pentra
Bilirubin, Total CP
The equation for the allometric line obtained using Passing-Bablock

regression procedure (9) is:
Y = 1.03 x - 2.43 mol/l with a correlation coefficient r2 = 0.9965.
Correlation (neonatal samples):
mol/l.
Y = 0.95 X + 0.085 mol/l with a correlation coefficient r2 = 0.993.
Interferences:
Haemoglobin: No significant influence is observed up to 500 mg/dl
(290 mol/l).
Triglycerides: No significant influence is observed up to 612.5 mg/dl
(7 mmol/l).
february 1999.
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.
8. Protocols for determination of limits of detection and limits of
quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,
Vol. 24, No. 34, 2004.
9. Passing H., Bablock W. A new biometrical procedure for testing the
equality of measurements from two different analytical methods.
J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.
10. Use of Anticoagulants in Diagnostics Laboratory Investigations.
WHO Publication WHO/DIL/LAB/99.1 rev.2, 2002.
11. Young D.S., Effects of Drugs on Clinical Laboratory Tests, 4th
Edition, Washington, DC, AACC Press, 1995, 3: 143-163.
12. Young D.S., Effects of
Preanalytical Variables on Clinical
Laboratory Tests, 2nd Edition, Washington, DC, AACC Press, 1997,
3: 120-132.
Other limitations are given by Young as a list of drugs and preanalytical

variables known to affect this methodology (11,12).
Calibration stability:
Conversion factor:
Software version: 4.4 - Application release: 7.xx
Warning
Reference
TH-Books Verlagsgesellschaft, 1998. p 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia:
W.B Saunders Company; 1999. p. 1125-77.
3. Rand R.N., di Pasqua A. A new diazo method for the determination
of bilirubin. Clin. Chem. 1962; 6:570-8.
ABX Pentra
Bilirubin, Total CP
ABX Pentra
Calcium AZ III CP
ABX Pentra Calcium AZ III CP

Ref.: A11A01894
Volume R1: 79 ml
Volume R2: 1 x 5 ml
Intended use
2008/09/09
A93A01221A EN

determination of Calcium in serum, plasma and
urine.
A11A01894
79 ml
Clinical Interest (1,2,3)

Calcium plays an essential role in many cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly, in
bone mineralization, in blood coagulation and in transmission of nerve
impulses. Calcium is present in plasma in three forms: free, bound to
proteins or complexed with anions as phosphate, citrate and
bicarbonate. Under physiological conditions, calcium balance is
determined by the relationship between calcium intake and calcium
absorption and excretion. Urinary excretion is an important
determinant of calcium retention in the body.
Decreased total calcium levels can be associated with diseases of the
bone apparatus (especially osteoporosis), kidney diseases (especially
under
dialysis),
defective
intestinal
absorption
and
hypoparathyroidism.
Increased total calcium can be measured in hyperparathyroidism,
malignant diseases with metastases and sarcoidosis. Calcium
measurements also help in monitoring of calcium supplementation
mainly in the prevention of osteoporosis.
Method (4,5,6,7)
Many colourimetric methods for determining calcium have been used
in the past. Connerty and Briggs described methods using alizarin 3sulphonate (4) and cresolphthalein complexone (5) whilst Gindler and
King have described a method using thymol blue (6).
There have been many subsequent modifications to these methods.
The method used here is based on the metallochromogen Arsenazo III.
Calcium ions (Ca2+) react with Arsenazo III (2,2-[1,8-Dihydroxy-3,6disulphonaphthylene-2,7-bisazo]- bisbenzenearsonic acid) at pH 6.75
to form an intense purple coloured chromophore. The absorbance of
the Ca-Arsenazo III complex is measured bichromaticcally at 660/700
nm. The resulting increase in absorbance of the reaction mixture is
directly proportional to the calcium concentration in the sample.
Arsenazo III has a high affinity (K = 1 x 10-7) for calcium ions (7) and
shows no interference from other cations normally present in serum,
plasma or urine.
Form-0846 Rev. 2
Ca++ + Arsenazo III
pH 6.75
Ca-Arsenazo III complex (purple)
HORIBA ABX
BP 7290
Reagents
ABX Pentra Calcium AZ III CP is ready-to-use.
Reagent : Arsenazo III
Imidazole buffer
Sodium azide
Surfactant
Stabilizers
pH 6.75 0.1
0.2 mmol/l
100 mmol/l
0.05%
ABX Pentra Calcium AZ III CP should be used according to this

otherwise.
Handling
Remove the cap of the cassette. If present, remove foam by using a
plastic pipette. Position the protective cap, ref. GBM0969 and place
the cassette in the refrigerated ABX Pentra 400 reagent compartment.
Calibrator
Control
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)
1 x 10 ml + 1 x 10 ml
ABX Pentra
Calcium AZ III CP


ABX Pentra Urine Control L/H, Ref. A11A01674
Specimen
Serum.
Urine
Do not use EDTA plasma : EDTA anticoagulant is unsuitable for analysis
because this compound chelates calcium, making it unavailable for
reaction with the reagent.
Assay Procedure
Waste Management
1. Please refer to local legal requirements.
2. This reagent contains sodium azide (0.05%) as a preservative. As
sodium azide may react with lead or copper to form explosive metal
azides, this reagent should be disposed of by flushing with copious
amounts of water.
Packaging deterioration
In case of packaging deterioration, do not use the reagent if the
dommage may influence the performance of the reagent.
General Precautions
2. As calcium is an ubiquitous ion, essential precaution must be taken
against accidental contamination. Only use disposable materials.
24 hours urine specimens have to be collected with HCl 6N (8). Non

acidified urines which have been refrigerated should be acidified and/
or heated at 56C for 15 minutes to redissolve any precipitate.
Stability of specimen (9):

Serum/plasma:
for up to 7 days at 20-25C.
for up to 3 weeks at 4-8C.
for up to 8 months at -20C.
Serum, plasma
Urine:
for up to 3 weeks at -20C .
Reference range (2)

Serum / Plasma:
Urine:
2.15 - 2.57 mmol/l (8.6 - 10.3 mg/dl )

Women: 6.24 mmol/24h (< 250 mg/24h)
Men: 7.49 mmol/24h (< 300 mg/24h)

Detection limit:
protocol (10) and equals 0.08 mmol/l.
EP17-A protocol (10) and equals 0.10 mmol/l.

the label if stored at 2-25C and contamination is avoided.
Stability after opening: refer to the paragraph Performance on ABX
Pentra 400.
ABX Pentra
Calcium AZ III CP

protocol (11).

Mean value mmol/l

2.30
2.89
1.80
2.42
3.32
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
CV %
0.46
0.51
0.93
0.70
0.73

tested 20 times according to the recommendations found in the CLSI
(NCCLS) EP05-A protocol (12).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

2.33
2.94
1.84
2.48
3.40
CV %
2.53
2.29
1.75
2.30
1.78
Measuring Range:
The assay confirmed a measuring range from 0.1 mmol/l to 4.50 mmol/
l, providing an upper linearity of 4.50 mmol/l, with an automatic postdilution up to 13.50 mmol/l.
found in the CLSI (NCCLS), EP6-A protocol (13).
Correlation:
mmol/l.
Y = 0.98 x - 0.02 with a correlation coefficient r2 = 0.9958.
Interferences:
Haemoglobin:

(500 mg/dl).
Triglycerides: No significant influence is observed up to 7 mmol/l
(612.5 mg/dl).
(as Intralipid, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 400 mol/l
(23.4 mg/dl).
Direct Bilirubin: No significant influence is observed up to 450 mol/l
(26.3 mg/dl).
Conversion factor:
mmol/l x 40.1 = mg/l
The calibration stability is 7 days.

Urine
Detection limit:
protocol (10) and equals 0.08 mmol/l.
EP17-A protocol (10) and equals 0.25 mmol/l.
protocol (11).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.73
2.55
1.02
2.49
4.03
CV %
1.14
0.71
0.92
0.74
0.52
ABX Pentra
Calcium AZ III CP

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.75
2.55
1.18
2.71
4.40
CV %
2.27
1.82
6.58
2.10
1.98
Measuring Range:
The assay confirmed a measuring range from 0.25 mmol/l to 4.50
mmol/l, with an automatic post-dilution up to 13.50 mmol/l.
The reagent linearity has been assessed up to 4.50 mmol/l, in
accordance with CLSI (NCCLS), EP6-A protocol (13).
Correlation:
83 patient samples (urine) are correlated with a commercial reagent
mmol/l.
Interferences:
Haemoglobin:

(500 mg/dl).
(612.5 mg/dl).
(25.6 mg/dl).
Acidification No significant influence is observed up to pH 2.
Conversion factor:
Warning
Reference
1. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: THBooks Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry.
3rd ed. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.
3. Matkovic V., Llich J.Z.; Andon M.B.; Hsieh L.C., Tzagournis M.A.,
Lagger B.J.; Goel PK., Am. J. Clin. Nutr., 1995, 62(2):417-25.
4. Connerty HV, Briggs AR.: Clin. Chem., 1965; 11: 716-28..
5. Connerty HV, Briggs AR.: Am. J. Clin. Path., 1966; 45: 290-6.
6. Gindler EM, Kin JD, Am.: J. Clin. Path., 1972; 58: 376-82.
7. Bauer PJ Anal.: Biochem, 1981; 110: 61-72.
8. NCCLS. Urinalysis and collection, transportation and preservation
of urine specimen; Approved guideline - 2nd Edition, NCCLS
document GP16-A2, Vol.21, No 19.
9. Use of anticoagulants in diagnostic laboratory investigations. WHO
publication WHO/DIL/LAB/99.1 Rev.2, 2002.
Vol. 24, No. 34, 2004.
Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,
february 1999.
16, april 2003.
22, No. 19, 2002.
3: 120-132.

ABX Pentra
Calcium CP
ABX Pentra Calcium CP

Ref.: A11A01633
Volume R1: 66 ml
Volume R2: 16.5 ml

determination of Calcium in serum, plasma
or urine.
2007/09/06
A93A00132N EN
A11A01633
66 ml
16.5 ml

bicarbonate. Decreased total calcium levels can be associated with
diseases of the bone apparatus (especially osteoporosis), kidney
diseases (especially under dialysis), defective intestinal absorption
and hypoparathyroidism. Increased total calcium can be measured in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of calcium
supplementation mainly in the prevention of osteoporosis.
Method
Photometric test using ortho-cresolphtalein complexone (OPC).
Cresolphthalein complexone reacts with calcium ions in alkaline
medium forming a red-violet color. Interference by magnesium is
eliminated by addition of 8-hydroxyquinoline.
Reagents
ABX Pentra Calcium CP is ready-to-use.
Reagent 1: Ethanolamine pH 10.7
0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline
34.5 mmol/l
Hydrochloric acid pH 1.1
100 mmol/l
ABX Pentra Calcium CP should be used according to this reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
Handling
plastic pipette. Position the respective protective cap, ref. GBM0969
on R1 and Ref. GBM0970 on R2 and place in the refrigerated ABX
Pentra 400 reagent compartment.
Calibrator
Form-0846 Rev. 2

HORIBA ABX
BP 7290
Control
1 x 10 ml + 1 x 10 ml

Specimen
Serum.
heparin Plasma.
Urine.
Do not use EDTA plasma.
Stability in: Serum /Plasma: 7 days
3 weeks
8 months
Urine:
2 days
4 days
3 weeks
at 20 - 25 C
at
4 - 8 C
at
- 20 C
at 20 - 25 C
at
4 - 8 C
at
- 20 C
Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to

dissolve calcium oxalate.
ABX Pentra
Calcium CP
Reference range (2)

Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women: < 250 mg/24 h (6.24 mmol/24 h)
Men:
< 300 mg/24 h (7.49 mmol/24 h)

the label if stored at 2-8C, protected from light, and contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of CO2
absorption from the air.
Pentra 400.
Assay Procedure
Waste Management
General Precautions
2. As calcium is an ubiquitous ion, essential precaution must be taken
against accidental contamination. Only use disposable materials.

Serum, Plasma
Detection limit:
and equals 0.04 mmol/l.
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

2.34
3.80
1.64
2.32
4.08
CV %
0.92
0.42
0.81
0.51
0.51

A variance analysis is carried out for 6 days out of 2 specimens of low
and high levels and 2 controls.
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

2.33
3.79
1.75
3.95
CV %
1.58
1.57
1.49
1.67

Low linearity: 0.04 mmol/l
High linearity: 5 mmol/l
Correlation:
100 patient samples are correlated with another method taken as
Y = 0.97 x + 0.03 with a correlation coefficient r2 = 0.9907 .
Interferences:
Haemoglobin: No significant influence is observed up to 195 mol/l.
Triglycerides: No significant influence is observed up to 7 mmol/l.
Total Bilirubin: No significant influence is observed up to 101 mol/l.
Conversion factor:
mmol/l x 40 = mg/l
Calibration stabilitya:
The calibration stability is 1 day.

protocol (5).
a.Modification from index M to N: Modification of calibration stability.
ABX Pentra
Calcium CP
Conversion factor:
mmol/l x 40 = mg/l
Urine

Detection limit:
protocol (5).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.69
3.15
1.09
2.96
7.22
CV %
0.71
0.70
0.64
0.44
1.37

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.64
3.11
1.45
6.20
CV %
2.44
2.21
3.15
2.91

Low linearity: 0.03 mmol/l.
High linearity: 6 mmol/l.

Warning
Reference
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:
46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining micro
quantities of calcium in biological materials. Anal. Biochem. 1967;
20:155-166.
february 1999.
september 1986.
19, 2002.
Correlation:
Interferences:
a.Modification from index M to N: Modification of calibration stability.
ABX Pentra
Calcium CP
ABX Pentra
Calcium CP
ABX Pentra Calcium CP (Rack)

Use in reagent rack
Ref. : A11A01633
Volume R1: 66 ml
Volume R2: 16.5 ml
Use in reagent rack

determination of Calcium in serum, plasma
or urine.
2008/04/21
A93A01182G EN
A11A01633
66 ml
16.5 ml

bicarbonate. Decreased total calcium levels can be associated with
diseases of the bone apparatus (especially osteoporosis), kidney
diseases (especially under dialysis), defective intestinal absorption
and hypoparathyroidism. Increased total calcium can be measured in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of calcium
supplementation mainly in the prevention of osteoporosis.
Method
HORIBA ABX
BP 7290

Reagent 2
Photometric test using ortho-cresolphtalein complexone (OPC).

Cresolphthalein complexone reacts with calcium ions in alkaline
medium forming a red-violet color. Interference by magnesium is
eliminated by addition of 8-hydroxyquinoline.

Reagent 1
Reagents
ABX Pentra Calcium CP is ready-to-use.
Reagent 1: Ethanolamine pH 10.7
0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline
34.5 mmol/l
Hydrochloric acid pH 1.1
100 mmol/l
ABX Pentra Calcium CP should be used according to this reagent
otherwise.
Handling
Transfer the required volume of Reagent 1 in a container 15, 10 or 4 ml.
Transfer the required volume of Reagent 2 in a container 10 or 4 ml.
Place Reagent 2 in position 2 of same selected sector using either:

Reagent container 10 ml
Reagent container 4 ml + its specific adaptor
Place the reagent rack in the refrigerated ABX Pentra 400 reagent
compartment.
Important : Discard the remaining reagent at the end of the day.
Calibrator
Form-0846 Rev. 2
Reagent 1 and Reagent 2 should be placed on the same reagent rack

sector A, B or C (see diagram below, sector A is taken as an example).
Place Reagent 1 in position 1 of one available sector using either:

ABX Pentra
Calcium CP
Control
Assay Procedure

1 x 10 ml + 1 x 10 ml


General Precautions
2. As calcium is an ubiquitous ion, essential precaution must be
taken against accidental contamination. Only use disposable
materials.

Specimen
Serum, Plasma
Serum.
heparin Plasma.
Urine.
Stability in: Serum /Plasma: 7 days
3 weeks
8 months
Urine:
2 days
4 days
3 weeks
Waste Management

at 20 - 25 C
at
4 - 8 C
at
- 20 C
at 20 - 25 C
at
4 - 8 C
at
- 20 C
Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to

dissolve calcium oxalate.
Reference range (2)

Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women: < 250 mg/24 h (6.24 mmol/24 h)
Men:
< 300 mg/24 h (7.49 mmol/24 h)
Detection limit:
protocol (5).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

2.34
3.80
1.64
2.32
4.08
CV %
0.92
0.42
0.81
0.51
0.51

the label if stored at 2-8C, protected from light, and contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of CO2
absorption from the air.
Stability after opening: 28 days if the reagents are stored in a capped
cassette between 2 and 8C.

A variance analysis is carried out for 6 days out of 2 specimens of low
and high levels and 2 controls.
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

2.33
3.79
1.75
3.95
CV %
1.58
1.57
1.49
1.67
ABX Pentra
Calcium CP

Correlation:
Y = 0.97 x + 0.03 with a correlation coefficient r2 = 0.9907 .
Normal control
Specimen 1
Specimen 2
Specimen 3
Conversion factor:
mmol/l x 40 = mg/l
The calibration stability is 4 hours.
Application releasea: 3.xx
CV %
0.71
0.70
0.64
0.44
1.37

Interferences:
Mean value mmol/l

1.69
3.15
1.09
2.96
7.22
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.64
3.11
1.45
6.20
CV %
2.44
2.21
3.15
2.91

Correlation:
Interferences:
Urine
Detection limit:
protocol (5).

Conversion factor:
mmol/l x 40 = mg/l
Application releaseb: 3.xx
Warning
a. Modification from index F to G: suppression of minor index.
b. Modification from index F to G: suppression of minor index.
ABX Pentra
Calcium CP
Reference
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:
46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining micro
quantities of calcium in biological materials. Anal. Biochem. 1967;
20:155-166.
february 1999.
september 1986.
19, 2002.
ABX Pentra
Cholesterol CP
ABX Pentra Cholesterol CP

Ref.: A11A01634
Volume: 90 ml

determination of Cholesterol in serum or plasma.
2008/11/17
A93A00142K EN
A11A01634
90 ml
Clinical Interest
Cholesterol is a component of cell membranes and a precursor for
steroid hormones and bile acids synthesized by body cells and
absorbed with food (1). Cholesterol is transported in plasma via
lipoproteins, namely complexes between lipids and apolipoproteins
(1). There are four classes of lipoproteins: high density lipoproteins
(HDL), low density lipoproteins (LDL), very low density lipoproteins
(VLDL) and chylomicrons. While LDL is involved in the cholesterol
transport to the peripheral cells, HDL is responsible for the cholesterol
uptake from the cells. The four different lipoprotein classes show
distinct relationship to coronary atherosclerosis (1). LDL-cholesterol
(LDL-C) contributes to atherosclerotic plaque formation within the
arterial intima and is strongly associated with coronary heart disease
(CHD) and related mortality. Even with total cholesterol within the
normal range an increased concentration of LDL-C indicates high risk.
HDL-C has a protective effect impeding plaque formation and shows an
inverse relationship to CHD prevalence. In fact, low HDL-C values
constitute an independent risk factor. The determination of the
individual total cholesterol (TC) level is used for screening purposes
while for a better risk assessment it is necessary to measure
additionally HDL-C and LDL-C.
In the last few years several controlled clinical trials using diet, life
style changes and / or different drugs (especially HMG CoA reductase
inhibitors [statins]) have demonstrated that lowering total cholesterol
and LDL-C levels reduce drastically CHD risk (2).
HORIBA ABX
BP 7290
Reagents
ABX Pentra Cholesterol CP is ready-to-use.
Reagent: Goods buffer
pH 6.7 50 mmol/l
Phenol
5 mmol/l
4-Aminoantipyrine
0.3 mmol/l
Cholesterol esterase (CHE) 200 U/l
Cholesterol oxidase (CHO)
50 U/l
Peroxidase
(POD)
3 kU/l
Sodium azide
0.95 g/l
ABX Pentra Cholesterol CP should be used according to this reagent
otherwise.
Method
CHOD-PAP: enzymatic photometric test.
Determination of cholesterol after enzymatic hydrolysis and oxidation
(3,4). The colorimetric indicator is quinoneimine which is generated
from 4-aminoantipyrine and phenol by hydrogen peroxide under the
catalytic action of peroxidase (Trinders reaction) (3).
Cholesterol ester + H2O
Cholesterol + O2
CHE
CHO
2H2O2 + 4-Aminoantipyrine + Phenol
Cholesterol + Fatty acid
Cholesterol-3-one + H2O2
POD
Handling
Calibrator
Quinoneime + 4H2O
Form-0846 Rev. 2
(CHE = Cholesterol Esterase, CHO = Cholesterol oxydase, POD = Peroxidase)
ABX Pentra
Cholesterol CP
Control
Waste Management


2. This reagent contains sodium azide (0.95 g/l) as a preservative. As
amounts of water.
General Precautions
This reagent is for professional in-vitro diagnostic use only.

Do not swallow. Avoid contact with skin and mucous membranes.
Take the necessary precautions for the use of laboratory reagents.
The reagent cassettes are disposable and should be disposed of in

Specimen
Serum.
Heparin Plasma or EDTA Plasma.
Stability: 7 days
7 days
3 months

at 20 - 25C
at
4 - 8C
at
-20C
Reference range (5)

Desirable:
< 200 mg/dl (5.2 mmol/l)
Borderline high risk: 200 - 240 mg/dl (5.2 - 6.2 mmol/l)
High risk:
> 240 mg/dl (> 6.2 mmol/l)
The European Task Force on Coronary Prevention recommends to lower
TC concentration to less than 190 mg/dl (5.0 mmol/l) and LDLcholesterol to less than 115 mg/dl (3.0 mmol/l) (2).

the label if stored at 2-8C, protected from light and contamination is
avoided.
Pentra 400.
Note: It has to be mentioned, that the measurement is not influenced
by occasionally occurring color changes, as long as the absorbance of
the reagent is < 0.3 at 546 nm.
Assay Procedure
1.
2.
3.
4.

Detection limit:
protocol (6).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

2.92
4.81
3.03
4.93
10.04
CV %
0.82
0.74
1.21
0.53
0.62

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

2.83
4.74
4.40
6.45
CV %
2.96
2.34
2.80
3.01
ABX Pentra
Cholesterol CP

Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:

5. Schaefer E.J., McNamara J. Overview of the diagnosis and

treatment of lipid disorders. In: Rifai N., Warnick G.R., Dominiczak
M.H., eds. Handbook of lipoprotein testing. Washington: AACC
press, 1997, 25-48.
february 1999.
september 1986.
19, 2002.
Conversion factor:
mmol/l x 0.387 = g/l
mmol/l x 38.7 = mg/dl
Warning
Reference
1. Rifai N., Bachorik P.S., Albers J.J. Lipids, lipoproteins and
apolipoproteins. In: Burtis C.A., Ashwood E.R., editors. Tietz
Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B. Saunders
Company; 1999. p. 809-861.
2. Recommendation of the Second Joint Task Force of European and
other Societies on Coronary Prevention. Prevention of coronary
heart disease in clinical practice. Eur. Heart J. 1998; 19, 14341503.
3. Artiss J.D., Zak B. Measurement of cholesterol concentration. In:
Rifai N., Warnick G.R., Dominiczak M.H., eds. Handbook of
lipoprotein testing. Washington: AACC Press, 1997, 99-114.
4. Deeg R., Ziegenhorn J. Kinetic enzymatic method for automated
determination of total cholesterol in serum. Clin. Chem. 1983; 29,
1798-1802.
a. Modification from index J to K: new application release.
ABX Pentra
Cholesterol CP
ABX Pentra
ABX Pentra CO2 RTU

Ref.: A11A01645
Volume: 2 x 20 ml
CO2 RTU

determination of Bicarbonate / total CO2
in serum or plasma.
2007/07/05
A93A00172I EN
A11A01645
2 x 20 ml
Clinical Interest (1)

Plasmatic bicarbonates are one of the principle buffer of the organism.
Their measurement is used in the diagnosis of the acid-base-balance
in the blood. This balance is based on the Henderson-Hasselbach
equation (pH=pK+log[bicarbonates/apCO2]) which implies that all
compensation mechanisms are intended for maintening the relation
(bicarbonates/apCO2) constant.
Elevated and decreased values indicate disorders associated with
disturbances of the metabolic and respiratory systems.
HORIBA ABX
BP 7290
Method
Enzymatic test using phosphoenolpyruvate carboxylase (PEPC) and a
stable NADH analog.
Phosphoenolpyruvate + HCO3-
PEPC + Mg
Oxaloacetate + Cofactor red.
2+
MDH
Oxaloacetate + H2PO4-
Malate + Cofactor
The reaction disturbs following equilibrium:

CO2 + H2O
H2CO3
Handling
Transfer the necessary Reagent 1 volume for one day of tests into a
reagent container 15, 10 or 4 ml.
H+ + HCO3-
(PEPC = Phosphoenolpyruvate carbolyxase, MDH = Malate Dehydrogenase)
This results in a conversion of CO2 to bicarbonate (HCO3-) which then

is included in the reaction. Therefore the total CO2 concentration is
measured.
The decrease of reduced cofactor concentration is measured at 405 nm
and is proportional to the concentration of total carbon dioxide in the
sample.
Reagents
ABX Pentra CO2 RTU is ready-to-use.
Reagent: Buffer
pH 7.5
Phosphoenolpyruvate (PEP)
12.5 mmol/l
Phosphoenolpyruvate carboxylase (PEPC)
> 400 U/l
Malate dehydrogenase (MDH)
> 4100 U/l
NADH analog
0.6 mmol/l
Activators, stabilizers, surfactant, preservative
ABX Pentra CO2 RTU

Reagent 1
compartment. Wait for 3 hours to stabilize the reagent.
Important: Discard the remaining reagent at the end of the day.
Calibrator
ABX Pentra CO2 Cal, Ref. A11A01648 (not included)
3 x 3 ml
Form-0846 Rev. 2
ABX Pentra CO2 RTU should be used according to this reagent notice.
HORIBA ABX cannot guarantee its performance if used otherwise.
ABX Pentra
CO2 RTU
Control

ABX Pentra CO2 Control, Ref. A11A01650 (not included)
3 x 3 ml

3 specimens of low, medium and high concentration and 1 control are
protocol (4).

Specimen
Serum.
heparin Plasma.
1. Serum or plasma should be separated from cells immediately.
2. Exposure of samples to air should be minimized.
3. Samples should be stored tightly sealed to prevent loss of carbon
dioxide and assayed as soon as possible after collection.
4. Do not use icteric samples.
Reference range (1)

Adults: 22 - 29 mmol/l (mEq/l).

Reagents, in unopened vials, are stable up to the expiry date on the
label if stored at 2 - 8 C protected from light and contamination is
avoided.
Once opened, the ABX Pentra CO2 RTU reagent is stable for 28 days
when stored at 2-8C.
Do not freeze the reagent.
Assay Procedure
Waste Management
General Precautions
1.
2.
3.
4.

The reagent vials should be discarded after use.
Please refer to the MSDS associated with the reagent.

Detection limit:
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

20.4
10.9
21.3
32.0
CV %
1.25
0.78
0.51
0.66

2 specimens of low and high levels and 1 control are tested in
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

20.7
9.5
31.6
CV %
4.77
7.7
5.93

High linearity: 60.8 mmol/l, with automatic post-dilution: 121.6 mmol/l.
Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:

ABX Pentra
CO2 RTU
The reagent is calibrated on H0. The calibration stability is checked by
testing 2 control specimens.
The calibration stability is 1 day by discarding the remaining reagent
at the end of the day.
Warning
Reference
1. Mller-Plathe O. Acid base balance and blood gases. In: Thomas L.,
editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: T.H. Books
Verlagsgesellschaft; 1998. p.318-329.
2. Norris K.A., Atkinson A.R., Smith W.G. Colorimetric enzymatic
determination of serum total carbon dioxide as applied to the
Vickers multichannel 300 discrete analyser. Clin. Chem. 1975;
21;1093-1101.
3. US patent #5,801,006.
february 1999.
september 1986.
19, 2002.
a. Modification from index H to I: suppression of minor index.
ABX Pentra
CO2 RTU
ABX Pentra
Creatinine CP
ABX Pentra Creatinine CP

Ref.: A11A01666
Volume R1: 28 ml
Volume R2: 28 ml

determination of creatinine in serum,
plasma and urine by colorimetry.
2007/07/04
A93A00182M EN
A11A01666
28 ml
28 ml
Clinical Interest
Creatinine is a product of the degradation of the creatine. It is a tiny
nitrogenised molecule eliminated primarily by the kidneys. Under
stable conditions of the muscular mass and proteic contribution,
creatininaemia is an excellent reflection of renal function. The
determination of urinary creatinine permits the calculation of
clarification, which is an independent parameter of diuresis and
proteic contribution.
HORIBA ABX
BP 7290
Method
Measurement of the formation of a colorimetric complex between the
creatinine and the alkaline picrate (Jaff). The speed of the formation
of this complex is proportional to the creatinine present in the sample.
This kinetic method reduces the effects of interfering substances.
Reagents

1 x 10 ml + 1 x 10 ml
ABX Pentra Creatinine CP is ready-to-use.

Reagent 1:
Reagent 2:
Picric acid
8.73 mmol/l
Sodium hydroxide
312.5 mmol/l
Disodium phosphate 12.5 mmol/l
ABX Pentra Creatinine CP should be used according to this reagent

notice. HORIBA ABX cannot guarantee its performances if used
otherwise.

Handling


on R1 and Ref. GBM0970 on R2 and place it in the position 45 of the
ABX Pentra 400 reagent compartment.
Specimen
Important : for a new cassette, wait for 30 minutes to stabilize the

temperature of the reagent.
Serum
Plasma in heparin and EDTA
Fresh centrifuged urine
Reference range(7)
Calibrator
Serum/Plasma:
Urine:
Form-0846 Rev. 2
Control
Men
8 - 13
0.8 - 1.3
71 - 115
0.8 - 2.0
7.1 - 17.7
Women
6 - 12
0.6 - 1.2
53 - 106
0.6 - 1.8
5.3 - 15.9
mg/l
mg/dl
mol/l
g/24 h
mmol/24 h

range.
ABX Pentra
Creatinine CP

Stability opening: refer to the paragraph "Performance on ABX Pentra
400".
Assay Procedure
Waste Management
General Precautions
1. Reagent, for professional in-vitro diagnostic use only
2. The reagent 2 contains diluted sodium hydroxide and is
consequently irritating to the eyes and the skin. In case of contact
with eyes, rinse generously with water and consult a specialist.
Avoid all contact with the skin; use gloves when handling.


A variance analysis out of 2 specimens of medium and high levels is
carried out (n=30).
Mean value mol/l
111
601
Specimen 1
Specimen 2
CV %
2.35
1.36

Low linearity: 10 mol/l
Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:
Glucose:

No significant influence is observed up to 22.5 mmol/l
Conversion factor:
Serum, Plasma
If the ABX Pentra Creatinine CP cassette is left on board the
instrument at all times, the cassette is stable for 21 days.
The reagent is calibrated each day.

Detection limit:
and equals 10 mol/l.

protocol (4).
Urine
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

114
299
53
137
676
CV %
1.58
0.66
2.09
0.71
0.39

If the ABX Pentra Creatinine CP cassette is left on board the
Detection limit:
a.Modification from index L to M: suppression of minor index.
ABX Pentra
Creatinine CP

3 specimens of low, medium and high concentration are tested 20 times
according to the recommendations found in the Valtec protocol (4).
Mean value mol/l
CV %
Specimen 1
2300
4.49
Specimen 2
6890
1.22
Specimen 3
15440
0.62
A variance analysis out of 2 specimens of medium and high levels is
carried out (n=30).
Specimen 1
Specimen 2
Mean value mol/l

7430
21100

september 1986.
19, 2002.
7. Tietz, N.W. Clinical guide to laboratory tests, 3rd Ed, (W.B.
Saunders eds. Philadelphia USA), (1995), 186.
CV %
2.47
1.57

Correlation:
46 patient samples correlated with a commercial reagent taken as
Conversion factor:
Warning
Reference
1. Houot O. - Interpretation of Clinical Laboratory Tests. Edited by Siest
G., Henny J., Schiele F. Biomedical Publications. (1985), 220-234.
2. Butler AR. The Jaff reaction. Identification of the coloured
species. Clin Chim Acta 1975; 59:227-32.
3. Vasiliades J. Reaction of alkaline picrate with creatinine. 1.
Kinetics and mechanism of formation of the mono-creatinine picric
acid complex. Clin Chem 1976; 22:1664-71.
a.Modification from index L to M: suppression of minor index.
ABX Pentra
Creatinine CP
ABX Pentra
Creatinine 120 CP
ABX Pentra Creatinine 120 CP

Test instructions for Mira instruments
Ref.: A11A01868
Volume: 1 x 27 ml
Intended use

determination of creatinine in serum, plasma and
urine by colorimetry.
2007/06/28
A93A01215C EN
A11A01868
1 x 27 ml

Creatinine, formed in the muscle, is a product of the degradation of
creatine phosphate, a high energy storage component. Creatininaemia
is quite constant (contrary to ureamia), it mainly depends of the
muscular mass. It is not very modified by food diet, age, sex or
exercise. Creatinine is extracted out of plasma by glomerular filtration
and then, eliminated in urine. The determination of urinary creatinine
permits the calculation of clarification, which is an independent
parameter of diuresis and proteic contribution.
Creatininaemia is an excellent reflection of renal function, however,
the serum creatinine level dont increase as long as the renal function
has not decreased of at least 50%.
HORIBA ABX
BP 7290
Calibrator
Method (3,4,5,6)
Creatinine reacts with alkaline picrate to produce a redish component
(Jaff reaction). The specificity of the measuring out has been
improved by the introduction of a kinetic method, however,
cephalosporin antibiotics still remain the main interfering substances.
The red color obtained, which is mesured at 500 nm by
spectrophotometry is directly proportional to the creatinine
concentration present in the sample .

Control
creatinine + picrate
Alkaline solution
creatinine/picrate complex (orange

to red color)
Reagents
ABX Pentra Creatinine 120 CP is ready-to-use.
Reagent:
Picric acid
Sodium hydroxide
Surfactants
pH 13.0 0.2 at 25C
10 mmol/l
260 mmol/l
ABX Pentra Creatinine 120 CP should be used according to this

reagent notice. HORIBA ABX cannot guarantee its performances if used
otherwise.
Handling
Form-0846 Rev. 2
Remove the R1, R2 cap of the cassette. If present, remove foam by

using a plastic pipette. Position the protective cap, ref. GBM0969 and
place in an ambient ABX Pentra 400 reagent compartment.
Important: for a new cassette, wait for 30 minutes to stabilize the
temperature of the reagent.

1 x 10 ml + 1 x 10 ml

Controls: ABX Pentra N Control, Ref. A11A01653
ABX Pentra
Creatinine 120 CP
Specimen
Serum
Plasma in lithium heparin
Plasma in EDTA
Pentra 400 analyser, according to an internal test protocol.
Stability:
Serum, plasma (17):
Urine (18):
3 days
4 days
3 months
2 days
6 days
6 months
Serum, plasma
at room temperature
at + 4C
at -20C
at 20-25C
at 4 - 8C
at -20C
Reference range
Serum/Plasma (8) :
Men
8 -13 mg/l
0.8 -1.3 mg/dl
71 -115 mol/l
Urine (24 hours)(7): 14-26 mg/kg/day
124-230 mol/kg/day
Women
6 -12 mg/l
0.6 -1.2 mg/dl
53 -106 mol/l
11-20 mg/kg/day
97-177 mol/kg/day

the label if stored tightly closed between 2-8C, protected from light
and contamination is avoided.
Pentra 400".
Waste Management
On board Reagent Stability (ambient area):

If the ABX Pentra Creatinine 120 CP cassette is left on board the
Detection limit:
protocol (15) and equals 0.18 mg/dl (16 mol/l).
protocol (9).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
CV %
1.51
0.39
4.08
0.79
0.62

tested in duplicate for 20 days (2 series per day) according to the
General Precautions
2. Irritant. Do not swallow. The reagent contains picric acid which
can explode when its dry. The reagent also contains an alcali.
Avoid swallow and contact with skin, mouth and eyes. The reagent
toxicity hasnt been established. In case of projection, rinse
generously affected zone with water.
R36/38 : Irritating to eyes and skin.
S24/25 : Avoid contact with skin and eyes.
S26 : In case of contact with eyes, rinse immediately with plenty
of water and seek medical advice.
S37 : Wear suitable gloves.
Mean value
mg/dl
mol/l
0.88
78.30
3.54
312.95
0.37
33.00
1.33
117.64
5.98
529.64
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
1.09
96.23
3.75
332.18
0.59
52.41
1.67
148.10
7.00
619.41
CV %
5.83
1.85
5.78
2.99
1.55
Measuring Range:
The assay confirmed a measuring range from 0.18 to 22.60 mg/dl (16.0
to 2000.0 mol/l), with an automatic post-dilution up to 67.8 mg/dl
(6000 mol/l).
The reagent linearity has been assessed up to 22.60 mg/dl (2000.0
mol/l) according to the recommendations found in the CLSI (NCCLS),
EP6-A protocol (11).
ABX Pentra
Creatinine 120 CP
Correlation:
mg/dl (46 to 1895 mol/l).
Y = 0.98 X - 0.04 (mg/dl)
Y = 0.98 X - 3.73 (mol/l)
with a correlation coefficient r2 = 0.9991.
Interferences:
No significant influence is observed up to 259 mg/dl
( 150 mol/l).
( 7 mmol/l) (as Intralipid, representative of lipemia).
Total Bilirubin: No significant influence is observed up to 16.9 mg/dl
( 286 mol/l).
Direct Bilirubin: No significant influence is observed up to 8.1 mg/dl
( 125 mol/l).
Glucose:
No significant influence is observed up to 11.7 g/l
( 65 mmol/l).
Total proteins No significant influence is observed up to 122 g/l

protocol (9).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
59.6
5278
128.0
11328
11.1
984
90.2
7987
240.8
21308
CV %
1.68
1.08
3.31
0.60
0.51
Haemoglobin:

Urine
On board Reagent Stability (ambient area):
If the ABX Pentra Creatinine 120 CP cassette is left on board the

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
60.5
5353
129.1
11426
12.7
1126
100.9
8930
245.6
21734
CV %
2.07
1.85
6.00
1.85
1.78
Measuring Range:
The assay confirmed a measuring range from 1.39 to 282.5 mg/dl (123
to 25000 mol/l), with an automatic post-dilution up to 857.5 mg/dl
(75000 mol/l).
The reagent linearity has been assessed up to 282.5 mg/dl (25000
EP6-A protocol (11).
Correlation:
mg/dl (628 to 24991 mol/l).
Y = 0.96 X - 0.73 (mg/dl)
Y = 0.96 X - 58.99 (mol/l)
Detection limit:
protocol (15) and equals 1.39 mg/dl (123 mol/l).
a.Modification from index B to C: New application release.
ABX Pentra
Creatinine 120 CP
Interferences:
Haemoglobin:

( 150 mol/l).
( 7 mmol/l) (as Intralipid, representative of lipemia).
( 250 mol/l).
Conversion factor:
Warning

february 1999.
16, april 2003.
22, No. 19, 2002.
3: 120-132.
Vol. 24, No. 34, 2004.
17. Chevillon I, Larrose C, Moreau N, Orsonneau JL. Conservation des
chantillons de sang avant analyse des paramtres biochimiques
les plus courants. Ann Biol. Clin., 1998; 56: 200-4.
18. Guder W.G., Zawta B., The Quality of Diagnostics Samples. Samples:
From the Patient to the Laboratory. 1st ed. Guder W.G., Narayanan
S., Zawta B. (WHILEY-VCH, Darmstadt, Germany), (2001), 50-51.
Reference
1. Allston, C.A., Non protein nitrogenous compounds and renal
function. Clinical Chemistry: Concepts and Application, Anderson,
S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993),
369.
2. Newman, D.J., Price C.P., Non protein nitrogen metabolite. Tietz
Fundamentals of Clinical Chemistry, 5me Ed., Burtis, C.A. &
Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001),
414.
3. Fabing D. L. and Ertinghausen G, Clin Chem 1971; 17:391.
4. Kroll M. H. and Elin R. J., Clin Chem 1983; 29:2044.
5. Butler AR. The Jaff reaction. Identification of the coloured
species. Clin Chim Acta 1975; 59:227-32.
6. Vasiliades J. Reaction of Alkaline Sodium Picrate with Creatinine.
Kinetics and Mechanism of Formation of the Mono-Creatinine
Picric Acid Complex. Clin.Chem., 1976; 22:1664-71.
7. Roberts W.L., McMillin G.A., Burtis C.A., Bruns D.E., Reference
Information for the Clinical Laboratory, TIETZ Textbook of Clinical
Chemistry and Molecular Diagnostics. 4me Ed; Burtis C.A.,
Ashwood E.R., Bruns D.E., (Elsevier Saunders eds. St Louis, USA);
2006, 2264.
ABX Pentra
Enzymatic Creatinine CP
Use in reagent rack
A11A01907
22 ml
8 ml
Intended use

determination of creatinine in serum, plasma and
urine by colorimetry.
2009/09/15
A93A01230A EN
A11A01907
22 ml
8 ml

Creatinine, formed in the muscle, is a product of the degradation of
creatine phosphate, a high energy storage component. Creatininaemia
is quite constant (contrary to ureamia), it mainly depends of the
muscular mass. It is not very modified by food diet, age, sex or
exercise. Creatinine is extracted out of plasma by glomerular filtration
and then, eliminated in urine. The determination of urinary creatinine
permits the calculation of clearance, which is an independent
parameter of diuresis and proteic contribution.
Creatininaemia is an excellent reflection of renal function, however,
the serum creatinine level dont increase as long as the renal function
has not decreased of at least 50%.
Reagents
Method
ABX Pentra Enzymatic Creatinine CP is ready-to-use.
This enzymatic method for creatinine utilizes a multi-step approach

ending with a photometric end-point reaction. The enzyme creatinine
amidohydrolase is used to convert creatinine to creatine.
Creatine is broken down to sarcosine and urea by creatine
amidinohydrolase. Further enzyme linked steps with sarcosine oxidase
and peroxidase yield a colored chromogen read at 545 nm.
Creatinine + H2O
Creatine + H2O
HORIBA ABX SAS

BP 7290
Creatinine amidohydrolase
Creatine
Creatine amidinohydrolase
Sarcosine + H2O + O2
Sarcosine oxidase
2 H2O2 + 4-Aminoantipyrine + ESPMT
Reagent 1:
Sarcosine + Urea
Reagent 2:
Glycine + HCHO + H2O2
Peroxidase
ESPMT: N-ethyl-N-sulfopropyl-m-toluidine
Quinoneimine Dye + 4 H2O
Buffer (pH 7.5 at 25C)

Creatine amidinohydrolase (microbial)
Sarcosine oxidase (microbial)
N-ethyl-N-sulfopropyl-m-toluidine
Ascorbate oxidase (botanical)
Stabilizers
Surfactants
Preservative
> 12,000 U/l

> 4,000 U/l
> 0.24 mmol/l
Buffer (pH 7.5 at 25C)

Creatinine amidohydrolase (microbial) > 135,000 U/l
4-aminoantipyrine
> 1.5 mmol/l
Peroxidase (botanical)
> 2,000 U/l
Stabilizers
Surfactants
Sodium azide
7.7 mmol/l
ABX Pentra Enzymatic Creatinine CP should be used according to this

reagent notice. The manufacturer cannot guarantee its performances
if used otherwise.
Handling
Form-0846 Rev. 3

on R1 and Ref. GBM0970 on R2 and place in the refrigerated ABX
Pentra 400 reagent compartment.
ABX Pentra
Calibrator
Control
1 x 10 ml + 1 x 10 ml
Serum/Plasma:
Men
6.2 - 11.0 mg/l
0.62 - 1.10 mg/dl
55 - 96 mol/l
14-26 mg/kg/day
124-230 mol/kg/day
Urine (24 hours):
Women
4.5 - 7.5 mg/l
0.45 - 0.75 mg/dl
40 - 66 mol/l
11-20 mg/kg/day
97-177 mol/kg/day

the label if stored tightly closed between 2-8C, protected from light
and contamination is avoided.
Pentra 400".
Packaging spoiling
In case of protective packaging spoiling, do not use the reagent if the
damages might have effect on the product performances.
Assay Procedure

Waste Management
Specimen
General Precautions
Serum
Plasma in lithium heparin
Plasma in EDTA

Stability(3):
Serum, plasma:
Urine:
2 days
7 days
3 months
2 days
6 days
6 months
at
at
at
at
at
at
20-25C
4-8C
-20C
20-25C
4 - 8C
-20C
Reference range (4)


2. This reagent contains less than 0.1 % of sodium azide as a
preservative. As sodium azide may react with lead and copper to
form explosive metal azides, this reagent should be disposed of by
flushing with copious amounts of water.

Pentra 400 analyser, according to an internal test protocol.
Serum, plasma
Pentra 400 reagent compartment is stable for 30 days.
ABX Pentra
Detection limit:
protocol (11) and equals 0.026 mg/dl (2.26 mol/l).
EP17-A protocol (11) and equals 0.11 mg/dl (10.0 mol/l).
protocol (5).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
0.90
79.50
4.05
358.38
0.56
49.66
1.52
134.57
6.46
571.61
CV %
2.18
0.54
2.86
1.08
0.29
Interferences:
Haemoglobin:

(290 mol/l).
(7 mmol/l) (as Intralipid, representative of lipemia).
(468 mol/l).
(170 mol/l).

recommendations found in the CLSI (NCCLS), EP5-A2 protocol (6).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
1.29
114.4
5.20
460.3
0.57
50.1
1.51
133.7
6.32
559.5
CV %
2.23
2.24
4.12
2.07
1.82
Measuring Range:
The assay confirmed a measuring range from 0.11 to 16.95 mg/dl (10.0
to 1500.0 mol/l), with an automatic post-dilution up to 50.85 mg/dl
(4500 mol/l).
The reagent linearity has been assessed up to 16.95 mg/dl (1500.0
EP6-A protocol (7).
Correlation:
CLSI (NCCLS), EP9-A2 protocol (8).
Values ranged from 0.34 to 16.13 mg/dl (30.3 to 1427.1 mol/l).
Y = 1.00 X - 0.01 (mg/dl)
Y = 1.00 X - 0.27 (mol/l)
Urine
Pentra 400 reagent compartment is stable for 30 days.
Detection limit:
protocol (11) and equals 0.66 mg/dl (58.2 mol/l).
EP17-A protocol (11) and equals 1.71 mg/dl (151 mol/l).
protocol (5).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
66.52
5887
148.78
13166
10.91
965
89.26
7899
216.98
19202
CV %
0.83
0.87
2.21
0.83
1.11
ABX Pentra

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
mg/dl
mol/l
70.5
6242
157.0
13891
11.2
994
92.2
8163
227.6
20143
CV %
3.06
3.08
4.84
2.55
2.58
Measuring Range:
The assay confirmed a measuring range from 3.56 to 282.5 mg/dl (315
to 25000 mol/l), with an automatic post-dilution up to 846.9 mg/dl
(75000 mol/l).
The reagent linearity has been assessed up to 282.5 mg/dl (25000
EP6-A protocol (7).
Correlation:
mg/dl (584.7 to 22239.4 mol/l).
Y = 0.96 X - 0.03 (mg/dl)
Y = 0.96 X + 1.37 (mol/l)
Interferences:
Haemoglobin:

(226 mol/l).
(7 mmol/l) (as Intralipid, representative of lipemia).
(228 mol/l).
Ascorbic Acid: No significant influence is observed up to 5.98 mg/dl
(340 mol/l).
Conversion factor:
Warning
Reference
1. Allston, C.A., Non protein nitrogenous compounds and renal
function. Clinical Chemistry: Concepts and Application, Anderson,
S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993),
369.
2. Newman, D.J., Price C.P., Non protein nitrogen metabolite. Tietz
Fundamentals of Clinical Chemistry, 5me Ed., Burtis, C.A. &
Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001),
414.
3. Use of Anticoagulants in Diagnostic Laboratory Investigations.
WHO Publication WHO/DIL/LAB/99.1 Rev. 2. 202, p28.
Chemistry and Molecular Diagnostics. 4me Ed; Burtis C.A.,
Ashwood E.R., Bruns D.E., (Elsevier Saunders eds. St Louis, USA);
2006, 2264.
Approved Guideline, CLSI (NCCLS) document EP5-A2, Vol. 19, No.
2, february 1999.
16, april 2003.
22, No. 19, 2002.
3: 120-132.
Vol. 24, No. 34, 2004.

ABX Pentra
Fructosamine
ABX Pentra Fructosamine

Ref.: A11A01679
Volume R1: 6 x 14 ml
Volume R2: 6 x 6 ml
Reagent for quantitative in-vitro determination of

glycated protein (fructosamine) in serum and plasma
by colorimetry.
2007/07/09
A93A00192J EN
A11A01679
6 x 14 ml
6 x 6 ml
Clinical Interest
Fructosamine serves as a time-averaged index of blood glucose levels
in the long term and enables monitoring of the glycaemic status in
diabetics (1). The determination of fructosamine is an appropriate
alternative for the determination of haemoglobin A1c in patients
presenting haemoglobin variants.
The concentrations of glycated proteins (glycohaemoglobin,
glycoalbumin, or glycated total proteins) are generally accepted for
the monitoring of glycose levels in diabetics. Various other methods
for determining fructosamine, such as affinity chromatography and the
thiobarbituric acid method, are more complicated, require more time
and are difficult to compare between laboratories (1,2). This test is
based on the nitrotetrazolium blue method (3) and permits a simple,
precise and easily automated determination of non-enzymatic
glycation of serum proteins. Since serum proteins have a shorter life
than haemoglobin (albumin half-life: 19 days; erythrocyte lifespan:
approx. 120 days), determinations of fructosamine permit controlling
the blood glucose status during a shorter period (1 to 3 weeks) than
those of glycated haemoglobin (6 to 8 weeks) (4). A modification of
the serum level of fructosamine indicates an increased imbalance in
the metabolism before a modification of the level of HbA1c occurs.
After treatment, the levels of fructosamine decrease more rapidly than
those of HbA1c (5).
Method
Reagent R1 + R2 (NBT reagent/buffer) has been added to the sample.
This colorimetric assay is based on the ability of ketoamines to reduce
nitrotetrazolium blue (NBT) in an alkaline environment. The speed of
formazan formation is directly proportional to the fructosamine
concentration. The presence of uricase in the reagent eliminates any
interference from uric acid, and the adding of detergent eliminates
matrix effects. The reaction speed is measured by photometry at 546
nm.
Reagents
Form-0846 Rev. 2
ABX Pentra Fructosamine is a bi-reagent kit.

Reagent 1 + Reagent 2:
Nitrotetrazolium blue
0.57 mmol/l
Sodium cholate
4.9 mmol/l
KCl
49 mmol/l
Potassium phosphate buffer
49 mmol/l
Potassium carbonate buffer, pH 10.3 250 mmol/l
Uricase (Arthrobacter species)
2.8 KU/I
Detergent
2.1%
HORIBA ABX
BP 7290
ABX Pentra Fructosamine should be used according to this reagent

otherwise.
Handling
1. Using the funnel included with the box, transfer the contents of a
vial of R2 into a vial of R1.
2. Mix the obtained solution by successive inversions of the vial. The
solution will be ready to use after 30 minutes.
3. Pour the necessary solution volume for one day of tests into a
reagent container, and place on a reagent rack in the refrigerated
ABX Pentra 400 reagent compartment. Discard the remaining
working solution at the end of the day.
ABX Pentra Fructosamine

Reagent 1 + Reagent 2
A slight colouring of the solution does not affect the outcome of the
assay.
Calibrator
ABX Pentra Fructo Cal, Ref. A11A01680 (not included)
ABX Pentra
Fructosamine
Control

ABX Pentra Fructo Control N, Ref. A11A01681 (not included)
ABX Pentra Fructo Control P, Ref. A11A01682 (not included)

label if stored at 2-8 C and protected from light.
Stability after reconstitution: 28 days

Specimen
Serum
Plasma in heparin or EDTA.
Storage (8) : 3 days
2 weeks
2 months
at 20-25 C
at
2-8 C
at
-20 C
Assay Procedure
Test instructions for automated systems other than ABX Pentra 400 are
Waste Management
General Precautions
2. Follow the customary precautions for laboratory practice (for
France: refer to the "Guide de Bonne Excution des Analyses"
(Guide of Good Analysis Execution)).
3. The reagent vials should be discarded after use.

Repeated freezing should be avoided. Mix well after thawing.

Samples containing precipitation should be centrifuged before analysis.
Number of tests: 600 Tests
Normal range (7,12)
Detection limit:
Fructosamine concentrations were determined in 555 subjects between

20 and 60 years of age that were apparently healthy.
After this study, the reference range was fixed at 205285 mol/l for
non-diabetic adults.
For a collective of patients with poorly controlled diabetes, the
average fructosamine value was 396 mol/l (reference range: 228563 mol/l).
A fructosamine concentration above the reference limits indicates a
hyperglycaemia preceding 1 to 3 weeks or more.
We recommend that each laboratory establish its own normal range, as
these values may vary according to the age, diet, sex, and geographic
repartition.
For diagnosis, the results of the determinations of fructosamine should
always be compared with anamnesis data and the results of clinical
and complementary examinations.
Note (13,14):
In cases of hydremia (during pregnancy, for example), it may be useful
to establish the relation between fructosamine and total proteins:

protocol (15).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

267.75
525.55
264.00
404.50
539.60
CV %
1.97
1.24
2.13
1.61
1.46
Reproducibility
2 specimens of medium and high levels and 2 controls have been
Fructosamine measured [mol/l] x 72 [g/l]

Fructosamine relative [mol/l] =
Total proteins measured [g/l]
A correction according to the albumin level is not recommended. A

dysproteinemia may lead to erroneous results.
ABX Pentra
Fructosamine
Normal control
Specimen 1
Specimen 2
Mean value mol/l

257.96
488.96
343.09
450.48
CV %
3.08
2.60
3.90
3.67

Correlation:
Interferences:
Haemoglobin: No significant influence is observed up to 278 mol/l
Calibration Stability:
7. Guder W.G., Narayanan S., Wisser H., Zawta B. List of Analytes

Preanalytical Variables. Broschure im Samples : From the Patient
to the Laboratory. Darmstadt : GIT Verlag, 1996.
8. Schleicher E.D., Vogt B.W. Clin. Chem. 1990 ; 36 : 136-139.
9. Glick M.R., Ryder K.W., Jackson S.A. Graphical Comparisons of
Interferences in Clinical Chemistry Instrumentation. Clin. Chem.
1986 ; 32 : 470-474.
10. Melzi dEril G. V., Bosoni T., Solerte S.B., Fioravanti M., Ferrari E.
Wien Klin Wochenschr Suppl 1990 ; 180 : 60-63.
11. Henrichs H.R. (ed.). European Fructosamine Workshop. Wien Klin
Wochenschr Suppl 1990 ; 180.
12. Schleicher E.D., Olgemller B., Wiedenmann E., Gerbitz K.D. Clin.
Chem. 1993 ; 39 : 625-628.
13. Passing H., Bablok W. A New Biometrical Procedure for Testing the
Equality of Measurements from Two Different Analytical Methods.
J. Clin. Chem. Clin. Biochem. 1983 ; 21 : 709-720.
14. Bablok W. et al. A General Regression Procedure for Method
Transformation. J. Clin. Chem. Clin. Biochem. 1988 ; 26 : 783-790.
february 1999.
september 1986.
19, 2002.
The calibration stability is 21 days by discarding the remaining

working solution at the end of the day.
Warning
Reference
1. Armbruster D.A. Clin. Chem. 1987 ; 33 : 2153-2163.
2. Furth A.J. Anal. Biochem. 1988 ; 175 : 347-360.
3. Johnson R.N., Metcalf P.A., Baker J.R. Clin. Chim. Acta. 1983 ; 127
: 87-95.
4. Tahara Y., Shima K. Diabetes Care 1995 ; 18 : 440-447.
5. Martina W.V., Martijn E.G., van der Molen M., Schermer J.G.,
Muskiet F.A. J. Clin. Chem. 1993 ; 39 : 2259-2265.
6. Kruse-Jarres J.D., Jarausch .J, Lehmann P., Vogt B.W., Rietz P.
Lab. Med. 1989 ; 13 : 245-253.
a.Modification from index I to J: suppression of minor index.
ABX Pentra
Fructosamine
ABX Pentra
Glucose HK CP
ABX Pentra Glucose HK CP

Ref.: A11A01667
Volume R1: 56 ml
Volume R2: 14 ml
Intended use

determination of Glucose HK in serum,
plasma and urinea by colorimetry.
2008/02/11
A93A01032K EN
A11A01667
56 ml
14 ml
Clinical Interest
Extra-cellular glucose is a source of energy for tissues. Its
concentration is closely regulated by various complex mechanisms.
Under normal physiological conditions, glucose is not excreted in the
urine.
The blood sugar level and glycosuria are the fundamental parameters
of the diagnosis, prognosis and surveillance of the treatment during
the development study of diabetes, of which there is very often a
clinical form.
The blood sugar level can also reflect certain pancreatic, metabolic or
endocrine disorders. Fever and proteic malnutrition cause a lowering
of this physiological parameter.
HORIBA ABX
BP 7290
Calibrator
Method
Enzymatic method (hexokinase)
Determination of glucose using the following reactions:
D-glucose + ATP
Glucose-6-phosphate + NAD
HK
Glucose-6-phosphate + ADP
G-6-PDH
D-gluconate-6-phosphate + NADH + H+
(HK = Hexokinase, G-6-PDH = Glucose-6-phosphate-dehydrogenase)
Reagents

Control
1 x 10 ml + 1 x 10 ml
ABX Pentra Glucose HK CP is ready-to-use.

Reagent 1: Pipes Buffer, pH 7.60
NAD
ATP
Sodium azide
Reagent 2: Hexokinase
G-6-PDH
Magnesium sulphate
Sodium azide
100 mmol/l
3.8 mmol/l
2.2 mmol/l
< 0.1 %
8500 U/l
8500 U/l
20 mmol/l
< 0.1 %
ABX Pentra Glucose HK CP should be used according to this reagent

notice. HORIBA ABX cannot guarantee its performances if used
otherwise.


ABX Pentra P Control, Ref. A11A01654, and
Form-0846 Rev. 2
Handling
Remove the caps of the cassette, place in the refrigerated ABX Pentra
a.Modification from index J to K: new application on urine.
ABX Pentra
Glucose HK CP
Specimen
Non-haemolysed serum
Plasma in heparin
Urine
Stability of urine (12):

For 24-hours collection urine, 5 ml of glacial acetic acid may be added
to the container before starting the collection.
Without preservatives, loss of glucose can be -40% after 24 hours at
room temperature.
Reference range
given here are used as guideline only.
Serum/plasma (10):
0.74 - 1.06 g/l
74 - 106 mg/dl
4.1 - 5.90 mmol/l
Urine (11,15):
< 0.84 mmol/l (< 15 mg/dl)
< 2.8 mmol/24 hours (0.5 g/24 hours)

Pentra 400".
Assay Procedure
Waste Management
General Precautions
2. Gently agitate any turbid reagents.
Serum, plasma
Detection limit:
protocol (6).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

5.4
14
1.7
5.2
14
CV %
0.7
0.8
1.2
0.5
0.7

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

5.4
14
5.6
15
CV %
1.98
1.18
2.01
1.47

found in the NCCLS, EP6-A protocol (8).
High linearity: 50 mmol/l, with automatic post-dilution: 150 mmol/l.
Correlation:
Y = 0.97 x + 0.11 with a correlation coefficient r = 0.9992.
ABX Pentra
Glucose HK CP
Interferences:
Haemoglobin:
Triglycerides:
Conversion factor:
mmol/l x 0.18 = g/l
mmol/l x 18 = mg/dl
Normal control
Specimen 1
Specimen 2
Specimen 3
Specimen 4
Specimen 5
Mean value mmol/l

1.64
16.17
0.81
5.81
9.72
27.57
46.04
CV %
3.57
2.62
4.82
1.21
2.96
2.74
1.59
Measuring Range:
The assay confirmed a measuring range from 0.11 to 50 mmol/l, with
an automatic post-dilution up to 150 mmol/l.
The reagent linearity has been assessed up to 50 mmol/l, according to
the recommendations found in the CLSI (NCCLS), EP6-A protocol (8).
Correlation:
reference according to the recommendations found in the CLSI
(NCCLS), EP9-A2 protocol (9). Values ranged from 0.18 to 50 mmol/l.
Y = 0.97 x + 0.04 mmol/l with a correlation coefficient r = 0.9973.
Urine
Interferences:

Detection limit:
protocol (6).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.61
16.00
1.04
9.98
29.65
CV %
1.25
0.42
2.56
0.73
0.76


Conversion factor:
mmol/l x 0.18 = g/l
mmol/l x 18 = mg/dl
Warning
ABX Pentra
Glucose HK CP
Reference
1. Kaplan L.A.: Carbohydrates and metabolites. Clin. Chem.: theory,
analysis and correlation, second edition by Kaplan L.A. et coll.
(1989), 850.
2. Bernard S. Biochimie Clinique. Edition Maloine, Paris (1982), 5,
135.
3. Burrin
JM., Price CP.Measurement of blood glucose.
Ann.Clin.Biochem. 22,(1985), 327.
4. Passey R.B, Gillum R.L, Fuller JB et coll. Evaluation and comparison
of 10 glucose methods and the reference method recommended in
the proposed product class standard. Clin.Chem.23 (1977) 131.
5. Tietz. Fundamentals of Clinical Chemistry. Chap.23.447 (2001).
february 1999.
16, April 2003.
22, No. 19, 2002.
10. Tietz, N.W., Clinical guide to laboratory tests. 3rd Ed., (W.B.
Chemistry and Molecular Diagnostics. 4me Ed., Burtis C.A.,
Ashwood E.R., Bruns D.E., (Elsevier Saunders eds., St Louis, USA),
2006, 2270-2271.
12. Sacks D.B.,M.B., Ch.B., F.R.C. Path., Carbohydrates, TIETZ Textbook
of Clinical Chemistry and Molecular Diagnostics. 4me Ed., Burtis
C.A., Ashwood E.R., Bruns D.E., (Elsevier Saunders Eds., St Louis,
USA), 2006, 869.
3: 120-132.
TH-Books Verlagsgesellschaft, 1998; 192-202.
ABX Pentra
Glucose PAP CP
ABX Pentra Glucose PAP CP

Ref.: A11A01668
Volume: 90 ml

determination of glucose PAP in serum,
2009/10/02
A93A00202N EN
A11A01668
90 ml
Clinical Interest
Extra-cellular glucose is a source of energy for tissues. Its concentration
is closely regulated by various complex mechanisms. Under normal
physiological conditions, glucose is not excreted in the urine.
The blood sugar level and glycosuria are the fundamental parameters
of the diagnosis, prognosis and surveillance of the treatment during
the development study of diabetes, of which there is very often a
clinical form.
The blood sugar level can also reflect certain pancreatic, metabolic or
endocrine disorders. Fever and proteic malnutrition cause a lowering
of this physiological parameter.
Method
Enzymatic determination of glucose using the following reactions
(Trinder method):
Glucose + O2
Glucose oxidase
2H2O2 + Phenol + 4AAP
Peroxidase
Glucose acid + H2O2
Quinoneimine + 4H2O
(4AAP = 4-aminoantipyrine)
Reagents
ABX Pentra Glucose PAP CP is ready-to-use.
Reagent: Phosphate buffer, pH 7.40 13.8 mmol/l
Phenol
10 mmol/l
4-aminoantipyrine
0.3 mmol/l
Glucose oxidase
10,000 U/l
Peroxidase
700 U/l
Sodium azide
< 0.1 %
ABX Pentra Glucose PAP CP should be used according to this reagent
notice. The manufacturer cannot guarantee its performances if used
otherwise.
Handling
HORIBA ABX SAS

BP 7290
Control
1 x 10 ml + 1 x 10 ml

Specimena
Plasma collected in fluoride or heparin-iodine-acetate or any anticoagulant inhibiting the glycolysis.
Centrifuged urine
Reference range(9)
Serum, plasma: 0.74 - 1.06 g/l
74 - 106 mg/dl
4.1 - 5.9 mmol/l
Form-0846 Rev. 3
Calibrator
a. Modification from index M to N: blood sugar level -> glycolysis.
ABX Pentra
Glucose PAP CP
Urine: < 0.1 mmol/l

range.

Pentra 400".
Assay Procedure
Waste Management
General Precautions
2. Gently agitate any turbid reagents before use.

Serum, Plasma
Detection limit:
protocol (5).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

4.96
12.81
2.38
6.19
16.46
CV %
0.41
0.40
0.62
0.30
0.49

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

5.01
13.08
5.95
16.61
CV %
1.23
1.12
1.44
1.05

Correlation:
Y = 1.01 x - 0.06 with a correlation coefficient r = 0.999.
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:

Conversion factor:
mmol/l x 0.18 = g/l
mmol/l x 18 = mg/dl
ABX Pentra
Glucose PAP CP
Urine


Detection limit:
protocol (5).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

/
14.9
5.59
12.38
34.97
CV %
/
1.8
4.1
1.1
1

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

/
14.6
12.87
35.79
CV %
/
4.34
3.29
2.08
Warning
Reference
1. Kaplan L.A.: Carbohydrates and metabolites. Clin. Chem.: theory,
analysis and correlation, second edition by Kaplan L.A. et coll.
(1989), 850.
135.
3. Trinder, P. Determination of glucose in blood using glucose
oxidase with an alternative oxygen acceptor. Ann. Clin. Biochem,
6, (1969), 24.
4. Burrin, JM., Price, CP. Measurement of blood glucose. Ann. Clin.
Biochem, 22, (1985), 327.
february 1999.
september 1986.
19, 2002.
9. Tietz, N.W., Clinical guide to laboratory tests. 3rd Ed., (W.B.

Correlation:
Conversion factor:
mmol/l x 0.18 = g/l
mmol/l x 18 = mg/dl
ABX Pentra
Glucose PAP CP
ABX Pentra
HDL Direct CP
ABX Pentra HDL Direct CP

Ref.: A11A01636
Volume R1: 62 ml
Volume R2: 21 ml
Intended use
2009/10/02
A93A00152L EN

determination of High-Density Lipoprotein
Cholesterol (HDL -C) in human serum or
A11A01636
62 ml
21 ml
Clinical Interest
Plasma lipoproteins are spherical particles containing varying amounts
of cholesterol, triglycerides, phospholipids and proteins. The
phospholipid, free cholesterol and protein constitute the outer surface
of the lipoprotein particle, while the inner core contains mostly
esterified cholesterol and triglyceride. These particles serve to solubilize
and transport cholesterol and triglyceride in the bloodstream.
The relative proportions of protein and lipid determine the density of
these lipoproteins and provide a basis on which to begin their
classification (1). The classes are: chylomicron, very-low-density
lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density
lipoprotein (HDL). Numerous clinical studies have shown that the
different lipoprotein classes have very distinct and varied effects on
coronary heart disease risk (2).
The principle role of HDL in lipid metabolism is the uptake and
transport of cholesterol from peripheral tissues to the liver through a
process known as reverse cholesterol transport (a proposed
cardioprotective mechanism) (3). Low HDL-C levels are strongly
associated with an increased risk of coronary heart disease and
coronary artery disease (4-9). Hence, the determination of serum HDLC is a useful tool in identifying high-risk patients. The Adult Treatment
Panel of the National Cholesterol Education Program (NCEP)
recommends that in all adults 20 years of age and over, a fasting
lipoprotein profile (total cholesterol, LDL cholesterol, HDL cholesterol
and triglyceride) should be obtained once every five years to screen for
coronary heart disease risk (10).
The reference method for the quantitation of HDL-C combines
ultracentrifugation and chemical precipitation to separate HDL from
other lipoproteins, followed by cholesterol measurement by AbellKendall analysis (11). This method is too time consuming and labor
intensive for use in routine analysis (12). The first routine methods
widely utilized by laboratories involved selective precipitation and
removal of LDL and VLDL, followed by the enzymatic measurement of
HDL-C in the supernatant fraction (11). Since these methods require
off-line pretreatment and separation steps the assay procedures
cannot be fully automated. As a result, routine determination of HDLC has suffered from long handling times and poor reproducibility.
HORIBA ABX SAS

BP 7290
* Licensed under PCT/JP97/04442, PCT/JP00/03860.
In the first reagent, non-HDL unesterified cholesterol is subject to an

enzyme reaction and the peroxide generated is consumed by a
peroxidase reaction with DSBmT yielding a colorless product.
The second reagent consists of a detergent capable of solubilizing HDL
specifically, cholesterol esterase (CE) and chromagenic coupler to
develop color for the quantitative determination of HDL-C.
This may be referred to as the Accelerator Selective Detergent
methodology.
HDL, LDL, VLDL, Chylomicrons
HDL
Accelerator + CO
DSBmT + Peroxidase
HDL Specific Detergent
HDL Cholesterol
Cholesterol esterase
Cholesterol oxidase
H2O2 + DSBmT + 4-AAP
Peroxidase
Non-Reactive LDL,
VLDL, Chylomicrons
HDL Disrupted
4 Cholestenone + H2O2
Color Development
(4-AAP = 4-Aminoantipyrine, CO = Cholesterol Oxidase, DSBmT = N,N-bis(4sulphobutyl)-m-toluidine-disodium)
Form-0846 Rev. 3
Method
ABX Pentra HDL Direct CP* assay is a homogeneous method for
directly measuring HDL-C levels in serum or plasma without the need
for any off-line pretreatment or centrifugation steps.
The method is in a two reagent format and depends on the properties
of a unique detergent, as illustrated. This method is based on
accelerating the reaction of cholesterol oxidase (CO) with non-HDL
unesterified cholesterol and dissolving HDL selectively using a specific
detergent.
S.A.S au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B
ABX Pentra
HDL Direct CP
Reagentsa
ABX Pentra HDL Direct CP is ready-to-use.

Calibrator: ABX Pentra HDL Cal, Ref. A11A01647
Reagent 1: Goods Buffer

Cholesterol oxidase
< 1000 U/l
Peroxidase
< 1300 ppg U/l
N,N-bis(4-sulphobutyl)- m-toluidine< 1 mM
disodium (DSBmT)
Accelerator
< 1 mM
Preservative
< 0.06 %
Ascorbic acid oxidase
< 3000 U/l
Reagent 2: Goods Buffer
Cholesterol esterase
< 1500 U/l
4-Aminoantipyrine (4-AAP)
< 1mM
Detergent
<2%
Preservative
< 0.06 %
ABX Pentra HDL Direct CP should be used according to this reagent
otherwise.
Handling
Specimen
Serum
Plasma in EDTA
Plasma in heparin-lithium
These specimens should be drawn from the patient after 12 - 14h fast.
Stability (11):
2 days at 4C
1 month at -20C with vials that have leak- and evaporation-proof seals.
2 years at -70C with vials that have leak- and evaporation-proof seals.
Serum: Collect whole blood by venipuncture and allow to clot.
Centrifuge and remove the serum as soon as possible after collection
(within 3 hours).
Plasma: Centrifuge and remove the plasma as soon as possible after
collection (within 3 hours).
Nota: Anticoagulants containing citrate should not be used.
Calibrator
ABX Pentra HDL Cal, Ref. A11A01647 (not included)
Reference range
The value of ABX Penra HDL Cal is assigned by procedures traceable

to the National Reference System for Cholesterol (NRS/CHOL).
Calibration materials have concentrations around the medical decision
level.
The expected values for serum HDL Cholesterol are as follows (13):
Control
given here are used as guideline only.
Men:
0.77 - 1.81 mmol/l (30 - 70 mg/dl)
Women: 0.77 - 2.19 mmol/l (30 - 85 mg/dl)
According to the NCEP, HDL values greater than or equal to 1.033
mmol/l (40mg/dl) are considered desirable, and values greater than
or equal to 1.550 mmol/l (60mg/dl) are considered to offer some
protection against coronary heart disease. Values below 1.033
mmol/l (40 mg/dl) are considered to be a significant independent
risk factor for coronary heart disease (9).
Endogeneous triglyceride levels gave acceptable performance up to
51.68 mmol/l (2000 mg/dl). Samples with triglyceride level > 51.68
mmol/l (> 2000 mg/dl) should not be diluted.
The NCEP recommends that dietary and/or drug treatment not be
based on a single HDL cholesterol result.
a.Modification from index K to L: modification of reagent composition.
ABX Pentra
HDL Direct CP

the label if stored at 2-8 C and protected from direct sunlight.
Pentra 400.
Assay Procedure
Waste Management
General Precautions
2. Do not pipette by mouth.

Sample volume: 2.4 l/test

Detection limita:
The detection limit is determined according to the CLSI (NCCLS), EP17A protocol (20) and equals 0.05 mmol/l.
protocol (14).
Mean value mmol/l
0.72
1.58
0.80
1.40
2.16
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

0.73
1.59
0.88
1.52
2.39
CV %
2.33
1.85
1.97
1.74
1.58
Measuring Range:
The assay confirmed a measuring range from 0.05 to 4.50 mmol/l.
The reagent linearity has been assessed up to 4.50 mmol/l, according
to the recommendations found in the CLSI (NCCLS), EP6-A protocol
(16).
Correlation:
mmol/l.
Y = 0.95 x + 0.01 mmol/l with a correlation coefficient r2 = 0.9921.
Interferences:

Normal control
Specimen 1
Specimen 2
Specimen 3

CV %
2.51
1.02
2.72
1.27
0.72
Haemoglobin:
Triglycerides:

GammaNo significant influence is observed up to 5000 mg/dl
globulins:
Conversion factor:
a.Modification from index K to L: modification of protocol.
ABX Pentra
HDL Direct CP
Warning
Reference
1. Gotto A.M., Lipoprotein metabolism and the etiology of
hyperlipidemia, Hospital Practice, 23; Suppl. 1, 4 (1988).
2. Crouse J.R. et al., Studies of low density lipoprotein molecular
weight in human beings with coronary artery disease, J. Lipid Res.,
26; 566 (1985).
3. Badimon J.J., Badimon L., Fuester V., Regression of
Atherosclerotic Lesions by High Density Lipoprotein Plasma
Fraction in the Cholesterol-Fed Rabbit, Journal of Clinical
Investigation, 1990; 85: 1234-1241.
4. Castelli W.P. et al., HDL Cholesterol and other lipids in coronary
heart disease, Circulation, 55;767 (1977).
5. Barr D.P., Russ E.M., Eder H.A., Protein-lipid relationships in
human plasma, Am. J. Med., 11; 480 (1951).
6. Gordon T. et al., High density lipoprotein as a protective factor
against coronary heart disease, Am. J. Med., 62; 707 (1977).
7. Williams P. et al., High density lipoprotein and coronary risk
factor, Lancet, 1; 72, (1979).
8. Kannel W.B., Castelli W.P., Gordon T., Cholesterol in the prediction
of atherosclerotic disease; New perspectives based on the
Framingham study, Am. J. Med., 90:85, (1979).
9. National Institutes of Health publication No. 93-3095, September,
(1993).
10. Special Communication, Executive Summary of the Third Report of
the National Cholesterol Education Program (NCEP) Expert Panel
on Detection, Evaluation, and Treatment of High Blood Cholesterol
in Adults (Adult Treatment Panel III), JAMA, Vol. 285, No. 19, May
16, 2001, pages 2486 - 2497.
11. Warnick G., Russell, Wood, Peter D., National Cholesterol Education
Program Recommendations for Measurement of High-Density
Lipoprotein Cholesterol: Executive Summary, Clinical Chemistry,
Vol. 41, No. 10, 1427-1433 (1995).
12. Grundy S. M. et. al., Summary of the Second Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation and Treatment of High Blood Cholesterol in Adults
(Adult Treatment Panel II), JAMA 1993, 269; 23; 3015-3023.
13. Tietz N. W., Clinical Guide to Laboratory Tests, W. B. Saunders Co.,
Philadelphia, 1986, p. 256.
february 1999.
16, April 2003.
22, No. 19, 2002.

3: 120-132.
quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A
(2004) 24(34) .
ABX Pentra
ABX Pentra Iron CP

Ref.: A11A01637
Volume R1: 60 ml
Volume R2: 20 ml
Iron CP

determination of Iron in serum and plasma.
2007/08/27
A93A00212J EN
A11A01637
60 ml
20 ml

Iron exists in the body as a component of hemoglobin and myoglobin
as well as bound to transferrin for the transport in plasma and stored
in ferritin. Increased iron concentrations occur in hemochromatosis
and liver damage. Decreased iron levels can be caused by anemia due
to malabsorption as consequence of gastrointestinal diseases or by
blood loss as a result of gastrointestinal lesions or heavy menstrual
bleeding. For the estimation of the body iron status the measurement
of transferrin and ferritin can provide more detailed information.
HORIBA ABX
BP 7290
Method
Photometric test using Ferene.
Iron bound to transferrin is released in an acidic medium as ferric iron
and is then reduced to ferrous iron in the presence of ascorbic acid.
Ferrous iron forms a blue complex with Ferene.
Transferrin(Fe3+)2
Fe2+ + 3 Ferene
Ascorbic acid, Buffer
2 Fe2+ + Transferrin
Ferrous Ferene (blue complex)
Reagentsa
ABX Pentra Iron CP is ready-to-use.
Reagent 1: Acetate buffer pH 4.5
Thiourea
Reagent 2: Ascorbic acid pH 2.5
Ferene
Thiourea
430 mmol/l
120 mmol/l
240 mmol/l
3 mmol/l
125 mmol/l
ABX Pentra Iron CP should be used according to this reagent notice.

Handlingb
plastic pipette.
compartment.
Control

Automated clinical chemistry analyser.
Specimen
Serum.
Heparin plasma (Do not freeze).
Separate serum at the latest 2h after blood collection to minimize
hemolysis.
Stability: 7 days
4 days
at
at
2 - 8 C
15 - 25 C
Form-0846 Rev. 2
Calibrator
a. Modification from index I to J: new volume R1 = 60 ml.
b. Modification from index I to J: new handling.
ABX Pentra
Iron CP
Reference range (5)

g/dl
mol/l
Children:
2 weeks
6 months
12 months
2 -12 years
63-201
28-135
35-155
22-135
11-36
5-24
6-28
4-24
Women:
25 years
40 years
60 years
37-165 6.6-29.5
23-134 4.1-24.0
39-149 7.0-26.7
Pregnant women:
12th gestational week 42-177 7.6-31.6
At term
25-137 4.5-24.5
6 weeks postpartum
16-150 2.9-26.9
Men:
25 years
40 years
60 years
40-155 7.2-27.7
35-168 6.3-30.1
40-120 7.2-21.5

is avoided.
Pentra 400.
Assay Procedure
Waste Management
General Precautions
2. Use only disposable material to avoid iron contamination. Rinse
glass material with diluted HCl and copious distilled water.

On board Reagent Stabilityb:

Detection limit:
protocol (6).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

20.67
34.04
9.03
17.19
121.91
CV %
1.89
1.50
2.56
2.32
1.32

Normal control
Specimen 1
Specimen 2
Mean value mol/l

20.94
34.24
13.33
91.58
CV %
2.98
2.61
3.61
1.78

Low linearity: 1.33 mol/l.
Correlation:
Interferences:
Direct Bilirubin: No significant influence is observed up to 289 mol/l.
Number of testsa: 282 tests

a. Modification from index I to J: new number of tests.
b. Modification from index I to J: new on board reagent stability.
ABX Pentra
Iron CP
Conversion factor:
mol/l x 5.58 = g/dl
mol/l x 0.0558 = mg/l
Warning
Reference
1. Wick M. Iron metabolism and its disorders. In: Thomas L., editor.
Clinical laboratory diagnostics. 1st ed. Frankfurt: T.H.-Books
Verlagsgesellschaft; 1998. p. 268-73.
2. Fairbanks V.F., Klee G.G. Biochemical aspects of hematology. In:
Burtis C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p.
1642-1710.
3. Higgins T. Novel chromogen for serum iron determinations. Clin.
Chem. 1981; 27:1619.
4. Artiss J.D., Vinogradov S., Zak B. Spectrophotometric study of
several sensitive reagents for serum iron. Clin. Biochem. 1981;
14:311-15.
february 1999.
september 1986.
19, 2002.
a. Modification from index I to J: modification of calibration stability.

b. Modification from index H to I: suppression of minor index.
ABX Pentra
Iron CP
ABX Pentra
Lactic Acid
ABX Pentra Lactic Acid

Ref.: A11A01721
Volume R1: 103 ml
Volume R2: 10 x 10 ml

determination of Lactic Acid in plasma by
colorimetry.
2009/09/23
A93A00222J EN
A11A01721
103 ml
10 x 10 ml
Clinical Interest
Lactic acid is the final product of anaerobic glycosis and represents the
main source of energy in certain tissues. It is considered to be the best
marker of the state of oxygenation in tissues.
It is mainly used for resuscitation in the treatment of states of shock
be it hypovolemic, toxi-infectious or cardiogenic as well as for treating
neonatal respiratory acidoses.
This determination is also used in athletic medicine to improve
athletic performance.
HORIBA ABX SAS

BP 7290
Method
Enzymatic colorimetric method. Trinder method.
Lactate is an intermediary metabolite of glycolysis involved in
maintaining the blood's pH value. Lactate oxidase triggers the release
of hydrogen peroxide, which reacts with 4-aminoantipyrine and ESPAS
to a coloured complex in the presence of peroxidase. The intensity of
the colouring is proportional to the amount of lactate present in the
sample.
Lactate + O2
Lactate oxidase
Handling
1. Dissolve reagent 2 in 10 ml of reagent 1 as shown on the vial of
reagent 2.
2. Wait approx. 15 minutes before use.
3. Pour the necessary reagent volume into an appropriate 10 or 15ml
container. Place it on the rack in the ABX Pentra 400 reagent
compartment.
Pyruvate + H2O2
Calibrator
2H2O2 + 4AAP + ESPAS
Peroxidase
Quinoneimine + 4H2O

(4 AAP = 4-aminoantipyrine, ESPAS = N-ethyl-N-sulfopropyl-m-anisidine)
Reagents
ABX Pentra Lactic Acid is lyophilized.
Reagent 1: Phosphate buffer, pH 7.50 100 mmol/l
ESPAS
1 mmol/l
Sodium azide
0.05 %
Sodium hydroxide
0.0009 %
Reagent 2: Lactate oxidase
450 U/l
Peroxidase
2,000 U/l
4-aminoantipyrine
0.40 mmol/l
Bovine albumin
0.3 %


Form-0846 Rev. 3
ABX Pentra Lactic Acid should be used according to this reagent

otherwise.
Control
ABX Pentra
Lactic Acid
Specimen
Plasma in heparin or EDTA
Capillary or venous blood should be collected from a subject at rest.
Reference range
< 0.200 g/l
< 20 mg/dl
< 2.19 mmol/l

Stability of ABX Pentra Lactic Acid after reconstitution:
8 hours at 20-25 C
7 days at 2-8 C
Assay Procedure
Waste Management
2. This reagent contains less than 0.1 % of sodium azide
(preservative). As sodium azide may react with lead and copper to
General Precautionsa
2. Avoid any contact between the reagent and the skin in order to
prevent contamination by lactate present in the sweat.
3. The reagent vials should be discarded after use.

Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.61
3.21
1.05
3.43
7.49
CV %
0.6
0.7
0.8
0.4
0.5

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.66
3.28
3.45
7.35
CV %
1.15
1.15
1.27
1.64

Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:

On-board Reagent Stability: 7 days

Detection limit:
protocol (4).
Conversion factor:
mmol/l x 90 = mg/l
mmol/l x 9 = mg/dl
a. Modification from index I to J: precaution addition.
ABX Pentra
Lactic Acid
Warning
Reference
1. Mizock B.A., Falk J.L., Lactic acidosis in critical illness, Crit. Care
Med., 20 (1), (1992), 80-93.
2. Kuhnle, H.F. et al., J. Clin. Chem., 16, (1977), 171.
3. Kuhnle, H.F. et al., Clin. Biochem., 35, (1989), 1992.
february 1999.
september 1986.
19, 2002.
ABX Pentra
Lactic Acid
ABX Pentra
LDL Direct CP
ABX Pentra LDL Direct CP

Ref.: A11A01638
Volume R1: 28 ml
Volume R2: 10 ml

determination of Low Density Lipoprotein
Cholesterol (LDL-C) in serum or plasma by
colorimetry.
2009/09/30
A93A00162M EN
A11A01638
28 ml
10 ml
Clinical Interest
Plasma lipoproteins are spherical particles containing varying amounts
of cholesterol, triglycerides, phospholipids and proteins. The
phospholipid, free cholesterol and protein constitute the outer surface
of the lipoprotein particle, while the inner core contains mostly
esterified cholesterol and triglyceride. These particles serve to solubilize
and transport cholesterol and triglyceride in the bloodstream.
The relative proportions of protein and lipid determine the density of
these lipoproteins and provide a basis on which to begin their
classification (1). These classes are: chylomicrons, very-low-density
lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density
lipoprotein (HDL). Numerous clinical studies have shown that the
different lipoprotein classes have very distinct and various effects on
coronary heart disease risk (2-4). The studies all point to LDL
cholesterol as the key factor in the pathogenesis of atherosclerosis and
coronary artery disease (CAD) (2-8), while HDL cholesterol has been
observed to have a protective effect. Even within the normal range of
total cholesterol concentrations, an increase in LDL cholesterol can
occur with an associated increased risk for CAD (4).
HORIBA ABX SAS

BP 7290
Reagent 2: MES Buffer (pH 6.3)

Detergent 2
N,N-bis(4-sulfobutyl)-toluidine,
disodium (DsBmT)
Preservative
< 1.0 %
< 1.0 mM
ABX Pentra LDL Direct CP should be used according to this reagent

otherwise.
Method
ABX Pentra LDL Direct CP assay is an homogeneous method for
directly measuring LDL-C levels in serum or plasma, without the need
for any off-line pretreatment or centrifugation steps.
The method is in a two reagent format and depends on the properties
of a unique detergent. This detergent (Reagent 1) solubilizes only the
non LDL lipoprotein particles. The cholesterol released is consumed by
cholesterol esterase and cholesterol oxidase in a non color forming
reaction. A second detergent (Reagent 2) solubilizes the remaining
LDL particles and a chromogenic coupler allows for color formation.
The enzyme reaction with LDL-C in the presence of the coupler
produces color that is proportional to the amount of LDL cholesterol
present in the sample.
Reagents
Form-0846 Rev. 3
ABX Pentra LDL Direct CP is ready-to-use.

Reagent 1: MES Buffer (pH 6.3)
Detergent 1
Cholesterol Esterase
Cholesterol Oxidase
Peroxidase
4-aminoantipiryrine
Ascorbic Acid Oxidase
Preservative
< 1.0 %
< 1500 U/l
< 1500 U/l
< 1300 ppg U/l
< 0.1 %
< 3000 U/l
Handling
plastic pipette.
compartment.
Calibrator
ABX Pentra LDL Cal, Ref. A11A01678 (not included)
Control
ABX Pentra
LDL Direct CP

Specimen
Patients are required to fast prior to blood collection.

Serum, EDTA-treated plasma or sodium heparinized plasma are the
recommended specimens.
Seruma : Collect whole blood by venipuncture and allow to clot.
Centrifuge and remove the serum as soon as possible (within 3
hours) (9).
Plasma : Specimens may be collected in EDTA or sodium heparin.
Centrifuge and remove the plasma as soon as possible after
collection (within 3 hours) (9).
If not analyzed promptly, specimens may be stored at 2-8 C for up to 5 days.
If specimens need to be stored for more than 5 days, they may be
preserved at -80 C. Samples may be frozen once.
Refer to NCCLS Document H18-A for further instructions on specimen
collection, handling and storage (10).
Nota: Anticoagulants containing citrate should not be used.
Reference range
The following NCEP cutpoints for patient classification are used for the
prevention and management of coronary heart disease (9).
LDL Cholesterol
Classification
< 130 mg/dl (< 3.36 mmol/l)
Desirable
130-159 mg/dl (3.36-4.11 mmol/l) Borderline High Risk
160 mg/dl (4.14 mmol/l)
High Risk
We recommend that each laboratory establishes its own reference range.

the label if stored at 2-8 C and protected from direct sunlight.
Pentra 400.
Assay Procedure
Waste Management
General Precautions
2. Do not pipet by mouth.

Detection limit:
protocol (11).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.58
1.94
2.88
3.66
4.94
CV %
1.01
2.82
0.91
1.00
0.63

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.57
1.92
4.05
4.95
CV %
5.59
6.39
3.94
4.04

Correlation:
a. Modification from index L to M: suppression of after collection.
ABX Pentra
LDL Direct CP
Interferences:
10. National Comittee for Clinical Laboratory Standards, Procedures for

the Handling and Processing of Blood Specimens, Approved
Guideline NCCLS Document H18-A, Number 12, Vol. 10, 1990.
february 1999.
september 1986.
19, 2002.
Conversion factor:
Warning
Reference
1. Centers for Disease Control/National Institutes of Health Manual,
Biosafety in Microbiological and Biomedical Laboratories, 1988.
I have also seen this as: Richardson J.H./ and Barkley W.E. eds.
Biosafety in Microbiological and Biomedical Laboratories, U.S.
Dept. of Health and Human Services, Public Health Service, HHS
Publication No. (CDC) 84-8395, Washington, DC,1984.
2. National Comittee for Clinical Laboratory Standards, Preparation
and Testing of Reagent Water in the Clinical Laboratory - Third
Edition; Approved Guideline NCCLS Document C3-A3, 1997.
3. Gotto A.M., Lipoprotein Metabolism and the Etiology of
Hyperlipidemia, Hospital Practice, 23: Suppl. 1, 4 (1988).
4. Crouse J.R. et al., Studies of low density lipoprotein molecular
weight in human beings with coronary artery disease, J. Lipid Res.,
26:566 (1985).
5. Badimon, J.J. et al., Regression of Atherosclerotic lesions by High
Density Lipoprotein Plasma Fraction in the cholesterol-Fed Rabbit,
Journal of Clinical Investigation, 85:1234 (1990).
6. Castelli W.P. et al., HDL Cholesterol anf Other Lipids in Coronary
Heart Disease, Circulation, 55:767 (1977).
7. Barr D.P. et al., Protein-lipid Relationships in Human Plasma, Am.
J. Med., 11:480 (1951).
8. Gordon T., et al., High Density Lipoprotein As a Protective Factor
Against Coronary Heart Disease, Am. J. Med., 62:707 (1977).
9. Bachorik P.S. et al., National Cholesterol Education Program
Recommendations for Measurement of Low-Density Lipoprotein
Cholesterol: Executive Summary, Clinical Chemistry, Vol.41, No.
10:1414 (1995).
ABX Pentra
LDL Direct CP
ABX Pentra
Magnesium RTU
ABX Pentra Magnesium RTU

Ref.: A11A01646
Volume: 2 x 25 ml

determination of Magnesium in serum and plasma.
2008/10/10
A93A00232M EN
A11A01646
2 x 25 ml
Deficiency of magnesium is a quite common disorder which can be caused
by malnutrition, malabsorption, renal loss and endocrinological
disturbances. Complications associated with decreased magnesium
concentrations are neuromuscular irritability (e.g. tremor, seizures) and
cardiac symptoms (e.g. tachycardia, arrhythmia). Decreased magnesium
concentrations are often related to decreased calcium and potassium levels,
taking into account that hypomagnesemia may be the primary cause of
hypocalcemia. Elevated magnesium values can be observed in dehydration,
renal disorders and after intake of excessive amounts of antacids and can
be associated with weakness of reflexes and low blood pressure.
HORIBA ABX
BP 7290
Method
Calibrator
Photometric test using xylidyl blue.

Magnesium ions form a purple colored complex with xylidyl blue in
alkaline solution. In presence of GEDTA, which complexes calcium
ions, the reaction is specific. The intensity of the purple color is
proportional to the magnesium concentration.

Reagents
ABX Pentra Magnesium RTU is ready-to-use.
Reagent: Ethanolamine pH 11.0
0.75 mol/l
GEDTA (Glycoletherdiamine -tetraacetic acid) 60 mol/l
Xylidyl blue
110 mol/l
Detergents
ABX Pentra Magnesium RTU should be used according to this reagent
notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Handling
Control

ABX Pentra Clean-Chem CP, Ref. A11A01755, 30 ml
Form-0846 Rev. 2
Specimen
ABX Pentra Magnesium RTU
Reagent 1
Serum.
Plasma.

Reagent container 4 ml + 2 specific adaptors.
Stability: 7 days at 20-25C

7 days at 4-8C
1 year at -20C
compartment.
ABX Pentra
Magnesium RTU
Reference range (1,5)

Neonates:
Children:
Women:
Men:

1.2 - 2.6 mg/dl (0.48 - 1.05 mmol/l)

1.5 - 2.3 mg/dl (0.60 - 0.95 mmol/l)
1.9 - 2.5 mg/dl (0.77 - 1.03 mmol/l)
1.8 - 2.6 mg/dl (0.73 - 1.06 mmol/l)

label if stored at 2 - 8 C protected from light and contamination is
avoided.
Do not freeze the reagent.
Assay Procedure
Waste Management
General Precautions
1.
2.
3.
4.

The reagent vials should be discarded after use.
Please refer to the MSDS associated with the reagent.

On board Reagent Stability: 7 days
CV %
3.19
2.80
2.63
2.79

Correlation:
Interferences:
Direct Bilirubin: No significant influence is observed up to 520 mol/l.

Detection limit:
protocol (6).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.03
1.76
0.9
1.31
Mean value mmol/l

1.0
1.72
0.65
0.93
1.18
Normal control
Specimen 1
Specimen 2
CV %
2.02
1.28
2.28
1.92
1.98

Conversion factor:
Warning
a. Modification from index L to M: new application release.
ABX Pentra
Magnesium RTU
Reference
3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1395-1457.
3. Mann C.K., Yoe J.H. Spectrophotometric determination of
magnesium with 1-Azo-2-hydroxy-3-(2.4-dimethylcarboxanilido)naphthalene-1-(2-hydroxybenzene). Anal. Chim. Acta, 1957;
16:155-160.
4. Bohoun C. Microdosage du magnesium dans divers milieux
biologiques. Clin. Chim. Acta 1962; 7:811-7.
5. Sitzmann FC. Normalwerte. Mnchen: Hans Marseille Verlag GmbH:
1986. p. 166.
february 1999.
september 1986.
19, 2002.
ABX Pentra
Magnesium RTU
ABX Pentra
ABX Pentra Phosphorus CP

Ref.: A11A01665
Volume: 29.5 ml
Phosphorus CP

determination of Phosphorus in serum,
2007/08/27
A93A00242O EN
A11A01665
29.5 ml
Clinical Interest
The phosphorus contained in the human body (80 % at bone level)
exists solely in the form of inorganic phosphate. The necessary level
of phosphates is provided via nutrition. Phosphate plays an important
role in the storage and distribution of the energy needed for cell
metabolism. Mainly located in the extracellular liquids, the phosphate
ions also have a buffering capacity.
Plasmatic concentration of mineral phosphorus depends upon diet and
intestinal absorption, renal elimination, tubular re-absorption and
bone metabolism. All these phenomena are under the influence of
regulatory hormones and calcium concentration (parathormone PTH,
calcitonin, and vitamin D). As a consequence, the regulation of
plasmatic phosphate is closely related to that of calcium. The
variations from phosphataemia (PTH stimulating the kidneys to
eliminate any phosphate and retain the calcium), which results from a
malfunction of the mechanisms mentioned above, are often inverse to
those of calcaemia.
Method
UV method using phosphomolybdate
The inorganic phosphorus is assayed according to the following
reaction:
Ammonium Molybdate + Sulphuric Acid
Phosphorus
Phosphomolybdate complex
Reagents
ABX Pentra Phosphorus CP is ready-to-use.
Reagent: Sulphuric acid
210 mmol/l
Ammonium molybdate 650 mol/l
ABX Pentra Phosphorus CP should be used according to this reagent
otherwise.
Handlinga
Remove cap of the cassette. If present, remove foam by using a plastic
pipette.
Position the protective cap, ref. GBM0969 and place in the refrigerated
HORIBA ABX
BP 7290
Control
1 x 10 ml + 1 x 10 ml

Specimen
Plasma in heparin
Fresh centrifuged urine.
Note: If the serum is lipaemic, create a serum blank by mixing 10 l
serum with 1 ml of a 9 g/l sodium chloride solution and read the
optical density at 340 nm.
Form-0846 Rev. 2
Calibrator
a. Modification fromindex N to O: new handling.
ABX Pentra
Phosphorus CP
Reference range(3)
Serum, plasma:
27 - 45 mg/l
2.7 - 4.5 mg/dl
0.87 - 1.45 mmol/l
Urine:
400 - 1300 mg/24 h
12.9 - 42.0 mmol/24 h
range.

Stability after opening: refer to paragraph the "Performance on ABX
Pentra 400".
Assay Procedure
Waste Management
General Precautions
2. IRRITANT. The reagent contains sulphuric acid (1.14%).
R36/38: May cause eye and skin irritations.
S26: In case of contact with eyes, rinse generously with water and
consult a specialist.
S37/39: Wear suitable gloves and eye/face protection.

Serum, Plasma
Detection limit:

protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

1.32
2.04
0.77
1.12
2.96
CV %
1.25
0.77
2.48
1.61
1.38

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.29
2.05
0.81
3.69
CV %
2.50
1.82
3.56
1.38

Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:
No significant influence is observed up to 72.5 mol/l

Conversion factor:
mmol/l x 31 = mg/l
a. Modification from index N to O: new on board reagent stability.
b. Modification from index M to N: suppression of minor index.
ABX Pentra
Phosphorus CP
Conversion factor:
mmol/l x 31 = mg/l

Detection limit:

Urine

protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

6.12
14.27
2.12
12.83
19.64
CV %
1.67
0.80
3.87
1.21
0.94

Normal control
Specimen 1
Specimen 2
Mean value mmol/l

6.28
14.79
2.29
29.81
CV %
2.82
2.06
5.95
1.97

Warning
Reference
1. Bourke E., Yanagawa N., Assessment of hyperphosphatemia and
hypophosphatemia. Clin. Lab. Med. 13 (1), (1993), 183-207.
2. Daly J.A., Ertingshausen G. Direct method for determining
inorganic phosphorus in serum with the Centrifichem. Clin. Chem.,
18, (1972), 263.
3. Endres, D.B. et Rude, R.K. Mineral and bone metabolism. Tietz
Fundamentals of Clinical Chemestry, Burtis, C.A. and Ashwood, E.R.
(W.B. Saunders eds. Philadelphia USA), (2001), 795.
february 1999.
september 1986.
19, 2002.
Correlation:
Interferences:
a. Modification from index N to O: new on board reagent stability.
b. Modification from index M to N: suppression of minor index.
ABX Pentra
Phosphorus CP
ABX Pentra
Total Protein CP
ABX Pentra Total Protein CP

Ref.: A11A01669
Volume: 61 ml
Diagnostic Reagent for quantitative in-vitro

determination of Total Proteins in serum by
colorimetry.
2007/09/06
A93A00252L EN
A11A01669
61 ml
Clinical Interest
Blood plasma is a concentrated solution of proteins, 60% of which is
albumin. Considered in their entirety, plasma proteins perform very
different tasks ranging from the maintenance of oncotic pressure to
the transport of various molecules. They are involved in the complex
mechanisms of blood coagulation and immunological reactions against
antibodies. Enzymes, contained at low levels, constitute one group of
the various proteins. An increase in their activity is a reliable indicator
for cell injuries.
The variations of the global level of proteins thus present a value of
diagnostic orientation, which however should be completed with a
more specific balance.
Hypoproteinaemias reflect low levels of albumin linked to an abnormal
renal protein escape, a protein synthesis defect (hepatic insufficiency)
or a deficiency disease.
Hyperproteinaemias are notably observed in connection with
dehydration symptoms, but they can also result from dysglobulinaemia
or a myeloma.
HORIBA ABX
BP 7290
Control
Biuret reaction
End-point method
In the presence of copper salts, serum proteins form a coloured
complex in an alkaline environment.

Reagents
ABX Pentra Total Protein CP is ready-to-use.

Method
Reagent:
Potassium iodide
Potassium sodium tartrate
Copper sulphate
Sodium hydroxide
6 mmol/l
21 mmol/l
6 mmol/l
58 mmol/l
ABX Pentra Total Protein CP should be used according to this reagent

notice. HORIBA ABX cannot guarantee its performance if used otherwise.
Handling
pipette. Position the protective cap, ref. GBM0969 and place in the
refrigerated ABX Pentra 400 reagent compartment.
Specimen
Serum
Reference range(8)
64
6.4
60
6.0
83 g/l
8.3 g/dl
78 g/l
7.8 g/dl

range.
Form-0846 Rev. 2
Calibrator
ABX Pentra
Total Protein CP

Pentra 400".
Assay Procedure
Waste Management
Normal control
Specimen 1
Specimen 2
Mean value g/l

52.5
51.8
44.9
66.69
CV %
2.48
2.35
2.79
2.17

Low linearity: 1.56 g/l
High linearity: 100 g/l, with automatic post-dilution: 300 g/l.
General Precautions
Correlation:
Interferences:

Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:


If the ABX Pentra Total Protein CP cassette is left on board the

Detection limit:
and equals 1.56 g/l.

protocol (4).

Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value g/l

51.6
51.7
42.3
60.6
79.3
CV %
1
1.2
1.1
0.9
0.7

Warning
Reference
135.
2. Gornall A. et al., Determination of serum proteins by means of the
biuret reaction, J. Biol. Chem., 177, (1949), 751.
3. Weichselbaum P.E., An accurate and rapid method for the
determination of proteins in small amounts of blood serum and
plasma, Am. J. Path, 16, (1946), 40.
february 1999.
a. Modification from index K to L: Modification of calibration stability.
ABX Pentra
Total Protein CP

september 1986.
19, 2002.
8. Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
ABX Pentra
Total Protein CP
ABX Pentra
Total Protein CP
ABX Pentra Total Protein CP (Rack)

Use in reagent rack
Ref.: A11A01669
Volume: 61 ml
Use in reagent rack

determination of Total Proteins in serum by
colorimetry.
2007/07/04
A93A01172F EN
A11A01669
61 ml
Clinical Interest
Blood plasma is a concentrated solution of proteins, 60% of which is
albumin. Considered in their entirety, plasma proteins perform very
different tasks ranging from the maintenance of oncotic pressure to
the transport of various molecules. They are involved in the complex
mechanisms of blood coagulation and immunological reactions against
antibodies. Enzymes, contained at low levels, constitute one group of
the various proteins. An increase in their activity is a reliable indicator
for cell injuries.
The variations of the global level of proteins thus present a value of
diagnostic orientation, which however should be completed with a
more specific balance.
Hypoproteinaemias reflect low levels of albumin linked to an abnormal
renal protein escape, a protein synthesis defect (hepatic insufficiency)
or a deficiency disease.
Hyperproteinaemias are notably observed in connection with
dehydration symptoms, but they can also result from dysglobulinaemia
or a myeloma.
Method
Biuret reaction
End-point method
In the presence of copper salts, serum proteins form a coloured
complex in an alkaline environment.
HORIBA ABX
BP 7290
ABX Pentra Total

Protein CP
Reagent
compartment.
Important: Discard the remaining reagent at the end of the day.
Reagents
ABX Pentra Total Protein CP is ready-to-use.
Reagent:
Potassium iodide
Potassium sodium tartrate
Copper sulphate
Sodium hydroxide
6 mmol/l
21 mmol/l
6 mmol/l
58 mmol/l
ABX Pentra Total Protein CP should be used according to this reagent

otherwise.
Handling
Form-0846 Rev. 2
Transfer the necessary Reagent volume for one day of tests into a
reagent container 15, 10 or 4 ml.
Place Reagent in position 1 of one available sector using either:
Calibrator
Control
ABX Pentra
Total Protein CP

Specimen
Serum
Reference range(8)
64
6.4
60
6.0
83 g/l
8.3 g/dl
78 g/l
7.8 g/dl

range.

Stability after opening: 1 month if the reagents are stored in a capped
cassette between 2 and 8C.
Assay Procedure
Waste Management
General Precautions
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value g/l

51.6
51.7
42.3
60.6
79.3
CV %
1
1.2
1.1
0.9
0.7

Normal control
Specimen 1
Specimen 2
Mean value g/l

52.5
51.8
44.9
66.69
CV %
2.48
2.35
2.79
2.17

Low linearity: 1.56 g/l
High linearity: 100 g/l, with automatic post-dilution: 300 g/l.
Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:



Detection limit:
and equals 1.56 g/l.
protocol (4).
Warning
a. Modification from index E to F: suppression of minor index.
ABX Pentra
Total Protein CP
Reference
135.
2. Gornall A. et al., Determination of serum proteins by means of the
biuret reaction, J. Biol. Chem., 177, (1949), 751.
3. Weichselbaum P.E., An accurate and rapid method for the
determination of proteins in small amounts of blood serum and
plasma, Am. J. Path, 16, (1946), 40.
february 1999.
september 1986.
19, 2002.
8. Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
ABX Pentra
Total Protein CP
ABX Pentra
Total Protein 100 CP
ABX Pentra Total Protein 100 CP

For ABX Pentra 400 Instrument
Ref.: A11A01867
Volume: 28 ml
Intended use
2007/07/10
A93A01214B EN

determination of Total protein in human serum or
A11A01867
28 ml
Clinical Interest (1)

Total protein is useful for monitoring gross changes in proteins levels
caused by various diseases states. It is usually performed in
conjunction with other tests such as serum albumin, liver function
tests or protein electrophoresis. An albumin/globulin ratio is often
calculated to obtain additional information.
Increased levels are found in dehydratation, multiple myeloma and
chronic liver diseases, whilst decreased levels are found in renal
disease and terminal liver failure.
HORIBA ABX
BP 7290
Method (2)
Biuret reaction.
The peptide bonds of protein react with the copper II ions in alkaline
solution to form a blue-violet complex ( the so-called biuret reaction),
each copper ion complexing with 5 or 6 peptides bonds (2). Tartrate is
added as a stabilizer whilst iodide is used to prevent auto-reduction of
the alkaline copper complex. The colour formed is proportional to the
protein concentration and is measured at 520-560 nm.
Reagents
ABX Pentra Total Protein 100 CP is ready-to-use.
Reagent:
Copper II Sulphate
Potassium Sodium Tartrate
Potassium Iodide
Sodium Hydroxide
pH 13.5 0.1 at 20C
12 mmol/l
32 mmol/l
30 mmol/l
600 mmol/l
ABX Pentra Total Protein 100 CP should be used according to this

otherwise.
Handling
Remove the R1, R2 cap of the cassette. If present, remove foam by
using a plastic pipette. Position the protective cap, ref. GBM0969 and
place in the refrigerated ABX Pentra 400 reagent compartment.
Calibrator
Form-0846 Rev. 2

Control

Specimen
Plasma in EDTA
Stability (3):
In closed tube at room temperature: up to 1 week
at 4-8C:
up to 1 month
In a deep-frozen state:
1 year
ABX Pentra

Recumbent patients:
64
6.4
60
6.0
83 g/l
8.3 g/dl
78 g/l
7.8 g/dl

the label if stored at 2-25 C.
Pentra 400".
Waste Management
General Precautions
2. Irritant. Do not ingest. If spilt, thoroughly wash affected areas
with water. Flush with plenty of water when disposing.
R36/38: Irritating to eyes and skin.
S24/25: Avoid contact with skin and eyes.
S26: In case of contact with eyes, rinse immediately with plenty
of water and seek medical advice.
S37: Wear suitable gloves.
3. The reagent vials are disposable and should be disposed of in

Pentra 400 analyser according to an internal test protocol.
On board Reagent Stability (refrigerated area):
If the ABX Pentra Total Protein 100 CP cassette is left on board the
Detection limit:
protocol (4) and equals 0.01 g/dl (0.10 g/l).
protocol (5).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
g/dl
g/l
6.80
68.0
5.19
51.9
4.15
41.5
6.41
64.1
8.76
87.6
CV %
0.82
1.13
1.51
0.84
0.53

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value
g/dl
g/l
6.78
67.8
5.13
51.3
4.11
41.1
6.44
64.4
8.88
88.8
CV %
1.41
1.55
1.56
1.62
1.27
Measuring Range:
The assay confirmed a measuring range from 0.10 to 10.0 g/dl (1.0 to
100 g/l), with an automatic post-dilution up to 20.0 g/dl (200 g/l).
The reagent linearity has been assessed up to 10 g/dl (100 g/l)
according to the recommendations found in the CLSI (NCCLS), EP6-A
protocol (7).
Correlation:
CLSI (NCCLS), EP9-A2 protocol (8). Values ranged from 1.00 g/dl to
9.00 g/dl (10.0 g/l to 90.0 g/l).
Y = 1.03 X - 1.95 (g/l)
Y = 1.03 X - 0.20 (g/dl)
Interferences:
Haemoglobin:
Triglycerides:
Do not use hemolysed samples.

(5 mmol/l), (as Intralipid, representative of lipemia).
(500 mol/l).
(375 mol/l).
ABX Pentra
Warning
Reference
1. Tietz N.W., (Ed), Textbook of Clinical Chemistry, W.B saunders
1986; p 579.
Information for the Clinical Laboratory. Tietz Textbook of Clinical
Chemistry and Molecular Diagnostics, 4th Ed., Burtis C.A.,
Ashwood, E.R., Bruns D.E. (Elsevier Saunders eds. St Louis USA),
(2006), 2293.
3. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: THBooks Verlagsgesellschaft; 1998, p.644-647.
Vol. 24, No. 34, 2004.
february 1999
16, april 2003.
22, No. 19, 2002.
3: 120-132.
a.Modification from index A to B: suppression of minor index.
ABX Pentra
ABX Pentra
Urinary Proteins CP
ABX Pentra Urinary Proteins CP

Ref.: A11A01642
Volume: 29 ml

determination of Total Proteins in urine.
2009/07/15
A93A00262F EN
A11A01642
29 ml
Elevated concentration of total protein in urine (proteinuria) can be
detected in the majority of kidney diseases. Primary and secondary
nephropathies may cause increased glomerular permeability or
decreased tubular reabsorption. Post-renal causes of proteinuria are
infections, bleedings or malignant diseases of the urinary tract.
Elevated urine protein levels can also be related to other acute
disorders like fever, as well as to physical or psychological stress.
HORIBA ABX SAS

BP 7290
Method
Photometric test using pyrogallol red.
Proteins together with pyrogallol red / molybdate form a red complex.
The color is directly proportional to the protein concentration.

Reagents
ABX Pentra Urinary Proteins CP is ready-to-use.
Reagent: Pyrogallol red

60 mol/l
Sodium molibdate 40 mol/l
Detergents

ABX Pentra Urinary Proteins CP should be used according to this

reagent notice. The manufacturer cannot guarantee its performance if
used otherwise.
Urine.
Handling
pipette.
Position the protective cap, ref. GBM0969 and place in the refrigerated
Calibrator
ABX Pentra TPU Cala, Ref. A11A01898 (not included)
3 x 3 ml
or
ABX Pentra Urine Cal, Ref. A11A01673 (not included)

3 x 1 ml
Form-0846 Rev. 3
Control
1 x 10 ml + 1 x 10 ml
Specimen
Stability: 1 day at 20-25C
2 days at
2-8C

24 - 141 mg/24 h

is avoided.
Pentra 400.
Assay Procedure
Waste Management
a. Modification from index E to F: new calibrator.

ABX Pentra
Urinary Proteins CP
General Precautions
Interferences:

Detection limit:
and equals 27 mg/l.
protocol (6).
Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Specimen 3
Mean value mg/l

188
370
194
588
1163
CV %
2.50
1.24
2.67
0.87
0.44

Control specimen 1
Control specimen 2
Specimen 1
Specimen 2
Mean value mg/l

184
357
238
1282
Correlation:
CV %
8.77
2.86
4.25
2.61

Low linearity: 27 mg/l
High linearity: 2944 mg/l, with automatic post-dilution: 5888 mg/l.
Haemoglobin: Do not use haemolysed samples.

Warning
Reference
1. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA,
Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed.
Philadelphia: W.B Saunders Company; 1999. p. 477-540.
2. Felgenhauer K. Laboratory diagnosis of neurological diseases. In:
Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: THBooks Verlagsgesellschaft; 1998. p. 1308-26.
3. Boege F. Urinary proteins. In: Thomas L. Clinical Laboratory
Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.
p. 382-400.
4. Orsonneau JL, Douet P, Massoubre C, Lustenberger P, Bernard S. An
improved pyrogallol red-molybdate method for determining total
urinary protein. Clin Chem 1989;35:2233-6.
5. Watanabe N, Kamei S, Ohkubo A, Yamanaka M, Ohsawa S, Makino
K et al. Urinary protein as measured with a pyrogallol redmolybdate complex. Manually and in a Hitachi 726 automated
analyzer. Clin Chem 1986;32:1551-4.
february 1999.
september 1986.
19, 2002.
ABX Pentra
Triglycerides CP
ABX Pentra Triglycerides CP

Ref. : A11A01640
Volume: 90 ml

determination of Triglycerides in serum and
2007/09/10
A93A00272K EN
A11A01640
90 ml
Clinical Interest
Triglycerides are composed of lipids, glycerol and fatty-acid esters,
which are transported in the plasma interacting with lipoproteins.
They mainly enter in the composition of chylomicra that are
discharged by enterocytes as well as the composition of very low
density lipoproteins synthesised by the liver (VLDL).
High concentrations of triglycerides are associated with various
pathologies such as cardiovascular diseases, diabetes, hyperlipidaemias
in connection with alcohol dependency, nephrotic syndromes,
hyperglyceridaemia types I and IV as well as hemostatic disorders.
Low concentrations can be found in malnutrition or hepatic infections.
The determination of triglycerides is used for the detection of these
pathologies, for diagnosis and for treatment monitoring.
Method
Enzymatic determination of triglycerides according to the following reactions:
Lipoprotein lipase
Triglycerides + H2O
Glycerol + ATP
Glycerokinase
Glycerol-3-Phosphate + O2
Glycerol + fatty acids
Glycerol-3-phosphate + ADP
Glycerol-3-phosphate Oxidase
2H2O2 + 4-AAP + p-Chlorophenol
Peroxidase
H2O2 + DHAP
Quinoneimine + 4H2O
HORIBA ABX
BP 7290
ABX Pentra Triglycerides CP should be used according to this reagent

otherwise.
Handling
Calibrator
(DHAP = Dihydroxyacetone phosphate, 4-AAP = 4-aminoantipyrine)
Control
Reagentsa
ABX Pentra Triglycerides CP is ready-to-use.
Form-0846 Rev. 2
Reagent:
Pipes free acid

Sodium hydroxide
Triton X-100
Magnesium salt
p-chlorophenol
ATP
Sodium azide
Potassium ferrocyanide
4-aminoantipyrine
Lipoprotein lipase
Glycerokinase
Glycerol phosphate Oxidase
Peroxidase
Distilled water
50 mmol/l
3.36 g/l
1 ml/l
14.8 mmol/l
2.69 mmol/l
3.14 mmol/l
7.99 mmol/l
9.94 mol/l
0.31 mmol/l
1.90 U/l
0.5050 KU/l
4.15 KU/l
0.4950 KU/l
qs 1l/l


ABX Pentra Clean-Chem CP, Ref. A11A01755, 30 ml
a. Modification from index J to K: new volume R1 = 90 ml.
ABX Pentra
Triglycerides CP
Specimen
Serum
Plasma in heparin
Reference range(12)
In a study conducted within the NCEP (National Cholesterol Education
Program, launched by the US Ministry of Health), the total cholesterol
values in serum have been classified according to the risk of
developing cardiovascular diseases:
Normal:
< 1.5 g/l
Low risk:
1.5 - 2.0 g/l
High:
2.0 - 5.0 g/l
Extremely high:
5.0 g/l
range.

Pentra 400".
The reagents' colour may change to brown in the course of time, but this
does not affect the reagent performance.

Detection limit:
protocol (8).
Normal control
Specimen 1
Specimen 2
Specimen 3
Waste Management
General Precautions
CV %
2.52
0.82
2.83
1.84
1.00

Assay Procedure
Mean value mmol/l

1.44
2.44
0.68
1.24
2.65
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

1.47
2.47
1.51
2.78
CV %
1.91
1.70
1.57
1.37


Correlation:
Interferences:

Number of testsa: 295 tests.
a. Modification from index J to K: new number of tests.
ABX Pentra
Triglycerides CP
Conversion factor:
Warning
Reference
1. Chait A., Brunzell JD., Severe hypertriglyceridemia: role of familial
and acquired disorders. Metabolism.,32 n3,(Mar. 1983), 209-214.
2. Eisenberg S., Lipoprotein abnormalities in hypertriglyceridemia:
significance in atherosclerosis., Am. Heart J.,(feb. 1987),555-561.
3. Masarei JRL., Puddey I.B., Rouse I.L. and al., Effects of alcohol
consumption on serum lipoprotein-lipid and apolipoprotein
concentrations. Results from an intervention study in healthy
subjects. Atherosclerosis, 60, (1986), 79-87.
4. Peynet J., Triglycrides, Monographie Bioforma, juin 1994, http:/
/bioch.ap-hop-paris.fr/analyses/Bioforma/TRIGLYCE.htm
5. Bucolo G., David H., Quantitative determination of serum
triglycerides by the use of enzymes. Clin. Chem., 19, (1973), 476.
6. Werner M., Gabrielson, D.G., Eastman, G. Clin. Chem. , 21, (1981),
268.
7. Annoni, G., Bottasso, B.M., Donato, M.F., Tripolo, A. Lab J.J. Res.
Lab. Med., 9, (1982), 115.
february 1999.
september 1986.
19, 2002.
12. Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III), Executive
Summary of the Third Report of the National Cholesterol Education
Program (NCEP). JAMA, (2001), 285, 2486.
a. Modification from index I to J: suppression of minor index.
ABX Pentra
Triglycerides CP
ABX Pentra
ABX Pentra Urea CP

Ref.: A11A01641
Volume R1: 60 ml
Volume R2: 15 ml
Urea CP

determination of Urea in serum, plasma and urine.
2007/07/02
A93A00292L EN
A11A01641
60 ml
15 ml

Urea is the nitrogen-containing end product of protein catabolism.
States associated with elevated levels of urea in blood are referred to
as hyperuremia or azotemia. Parallel determination of urea and
creatinine is performed to differentiate between pre-renal and postrenal azotemia. Pre-renal azotemia, caused by e.g. dehydration,
increased protein catabolism, cortisol treatment or decreased renal
perfusion, leads to increased urea levels, while creatinine values
remain within the reference range. In post-renal azotemias, caused by
the obstruction of the urinary tract, both urea and creatinine levels
rise, but creatinine in a smaller extent. In renal diseases urea
concentrations are elevated when the glomerular filtration rate is
markedly reduced and when the protein intake is higher than 200 g/
day.
Method
HORIBA ABX
BP 7290
Calibrator
Urease - GLDH: enzymatic UV test.

Urea + 2H2O
Urease
2-Oxoglutarate + NH4+ + NADH
GLDH
2NH4+ + 2 HCO3L-Glutamate + NAD+ + H2O
(GLDH = Glutamate dehydrogenase)
Reagents
ABX Pentra Urea CP is ready-to-use.
Reagent 1: TRIS
pH 7.8
2-Oxoglutarate
ADP
Urease
GLDH (Glutamate dehydrogenase)
Sodium azide
Reagent 2: NADH
Sodium azide
150 mmol/l
8.75 mmol/l
0.75 mmol/l
7.5 kU/l
1.25 kU/l
< 1 g/l
1.32 mmol/l
< 1 g/l
ABX Pentra Urea CP should be used according to this reagent notice.

Control
1 x 10 ml + 1 x 10 ml

Specimen
Handling
Serum.
heparin plasma.
Fresh Urine.
Form-0846 Rev. 2
ABX Pentra
Urea CP
Stability in: Serum/Plasma: 7 days

7 days
1 year
Urine:
2 days
7 days
1 month
at 20-25C
at
4-8C
at
-20C
at 20-25C
at
4-8C
at
-20C


Reference range
In Serum / Plasma (1) :
[mg/dl]
Adults:
Global
17-43
Women < 50 years 15-40
Women > 50 years 21-43
Men < 50 years
19-44
Men > 50 years
18-55
Children:
1-3 years
11-36
4-13 years
15-36
14-19 years
18-45
Serum, Plasma
[mmol/l]
2.8-7.2
2.6-6.7
3.5-7.2
3.2-7.3
3.0-9.2
1.8-6.0
2.5-6.0
2.9-7.5
Urea/Creatinine ratio (1) :

25 - 40 [(mmol/l)/(mmol/l)]
20 - 35 [(mg/dl)/(mg/dl)]
in Urine (2) :
20 - 35 g/24h (338 - 583 mmol/24h)

is avoided.
Pentra 400.
Assay Procedure
Waste Management
2. This reagent contains sodium azide (0.95 g/l) as a preservative. As
amounts of water.

Detection limit:
protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

6.68
25.93
2.15
7.43
30.45
CV %
2.27
1.66
2.76
1.58
1.80

2 specimens of medium and high levels and 2 controls are tested in
Normal control
Specimen 1
Specimen 2
Mean value mmol/l

6.57
25.54
6.86
24.98
CV %
2.14
1.93
2.14
1.97

General Precautions
2. Do not swallow. Avoid contact with skin and mucous membranes.
ABX Pentra
Urea CP
Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:


Normal control
Specimen 1
Specimen 2
Mean value mmol/l

128.58
216.27
198.13
547.82
CV %
3.80
4.13
3.42
3.08

Correlation:
Urine




Detection limit:
protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mmol/l

129.13
223.73
91.55
173.65
521.62
a.Modification from index K to L: suppression of minor index.
CV %
1.24
0.74
1.76
1.44
0.72
Warning
Reference
2. Burtis C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
1838.
3. Talke H., Schubert G.E. Enzymatische Harnstoffbestimmung in Blut
und Serum im optischen Test nach Warburg (Enzymatic
determination of urea in blood and serum with the optical test
according to Warburg). Klin. Wschr. 1965; 43:174-175.
february 1999.
b.Modification from index K to L: suppression of minor index.
ABX Pentra
Urea CP

september 1986.
19, 2002.
ABX Pentra
ABX Pentra Urea CP

Ref.: A11A01641
Volume R1: 60 ml
Volume R2: 15 ml
Urea CP
Blood Urea Nitrogen
Intended use
2007/09/10
A93A01216C EN

determination of Blood urea Nitrogen in serum,
plasma and urine.
A11A01641
60 ml
15 ml

Urea is the nitrogen-containing end product of protein catabolism.
States associated with elevated levels of urea in blood are referred to
as hyperuremia or azotemia. Parallel determination of urea and
creatinine is performed to differentiate between pre-renal and postrenal azotemia. Pre-renal azotemia, caused by e.g. dehydration,
increased protein catabolism, cortisol treatment or decreased renal
perfusion, leads to increased urea levels, while creatinine values
remain within the reference range. In post-renal azotemias, caused by
the obstruction of the urinary tract, both urea and creatinine levels
rise, but creatinine in a smaller extent. In renal diseases urea
concentrations are elevated when the glomerular filtration rate is
markedly reduced and when the protein intake is higher than 200 g/
day.
HORIBA ABX
BP 7290
Calibrator
Method (3)
Control
Urease - GLDH: enzymatic UV test.

Urea + 2H2O
Urease
2-Oxoglutarate + NH4+ + NADH
GLDH
2NH4+ + 2 HCO3L-Glutamate + NAD+ + H2O
(GLDH = Glutamate dehydrogenase)

1 x 10 ml + 1 x 10 ml
Reagents
ABX Pentra Urea CP is ready-to-use.
Reagent 1: TRIS
pH 7.8
2-Oxoglutarate
ADP
Urease
GLDH (Glutamate dehydrogenase)
Sodium azide
Reagent 2: NADH
Sodium azide
150 mmol/l
8.75 mmol/l
0.75 mmol/l
7.5 kU/l
1.25 kU/l
< 1 g/l
1.32 mmol/l
< 1 g/l
ABX Pentra Urea CP should be used according to this reagent notice.

Handling
Form-0846 Rev. 2


ABX Pentra P Control, Ref. A11A01654, and
Specimen
Serum.
heparin plasma.
Fresh Urine.
ABX Pentra
Urea CP
Stability in: Serum/Plasma: 7 days

7 days
1 year
Urine:
2 days
7 days
1 month
at 20-25C
at
4-8C
at
-20C
at 20-25C
at
4-8C
at
-20C
General Precautions
1.
2.
3.
4.

Do not swallow. Avoid contact with skin and mucous membranes.
The reagent cassettes are disposable and should be disposed of in
Reference range
BUN
[mg/dl]
Serum/plasma (1):
Adults:
Global
Women < 50 years
Women > 50 years
Men < 50 years
Men > 50 years
Children:
1-3 years
4-13 years
14-19 years
Urine (8):
7.9-20.2
7.3-18.8
9.8-20.2
9.0-20.5
8.4-25.8
5.1-16.8
7.0-16.8
8.1-21.1
BUN [mg/24h]
1207-1993

the label if stored at 2 - 8 C and contamination is avoided.
Pentra 400.
Assay Procedure
Serum, plasma
Detection limit:
and equals 0.9 mg/dl.
protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
CV %
2.27
1.66
2.76
1.58
1.80

Waste Management
2. This reagent contains less than 0.1% of sodium azide as a
preservative. As sodium azide may react with lead or copper to
Mean value mg/dl

18.7
72.8
6.0
20.9
85.5
Normal control
Specimen 1
Specimen 2
Mean value mg/dl

18.5
71.7
19.2
70.1
CV %
2.14
1.93
2.14
1.97

Low linearity: 0.9 mg/dl
High linearity: 140.3 mg/dl, with automatic post-dilution: 701.5 mg/dl.
ABX Pentra
Urea CP
Correlation:
reference according to the recommendations found in CLSI (NCCLS),
EP9-A2 protocol (7).
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:



Normal control
Specimen 1
Specimen 2
Mean value mg/dl

361
607
556
1538
CV %
3.80
4.13
3.42
3.08

Low linearity: 17 mg/dl
High linearity: 2806 mg/dl
Correlation:
reference according to the recommendations found in CLSI (NCCLS),
EP9-A2 protocol (7).
Y = 0.92 X + 32 (mg/dl) with a correlation coefficient r2 = 0.996.
Urine


Conversion factor (1)

Detection limit:
and equals 17 mg/dl.
protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mg/dl

363
628
257
488
1465
CV %
1.24
0.74
1.76
1.44
0.72
Urea (mmol/l) = Urea (mg/dl) x 0.1665

BUN (mmol/l) = BUN (mg/dl) x 0.3561
BUN (mg/dl) = Urea (mg/dl) / 2.14
Warning
Reference
2. Burtis C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
1838.
3. Talke H, Schubert GE. Enzymatic Urea Determination in the Blood
and Serum in the Warburg Optical Test. Klin. Wochenschr; 1965;
43: 174-5.
a.Modification from index B to C: new application release.
ABX Pentra
Urea CP

february 1999.
16, april 2003.
22, No. 19, 2002.
Chemistry and Molecular Diagnostics. 4th Ed., Burtis C.A., Ashwood
E.R., Bruns D.E., (Elsevier Saunders eds., St Louis, USA), 2006,
2301.
3: 120-132.
ABX Pentra
Uric Acid CP
ABX Pentra Uric Acid CP

Ref.: A11A01670
Volume R1: 60 ml
Volume R2: 15 ml

determination of Uric Acid in serum, plasma
and urine by colorimetry.
2007/07/02
A93A00282K EN
A11A01670
60 ml
15 ml
Clinical Interest
Uric acid is a waste product resulting from hepatic synthesis. It also
emerges from the degradation of nucleic acids of dietary and cellular
origin. The kidney and the intestines assure its decomposition.
Biologically, uric acid is not a constant value, and its level varies
according to the diet.
Hyperuricaemia is present in the origin of the development of urate
thesaurismosis, commonly known as gout, which causes articular
inflammations following the precipitation of uratic microcrystals, as
well as renal disorders.
Hyperuricaemias may be primitive, linked to enzymatic deficiencies
innate to the metabolism (malnutrition, ethnic and inherited factors),
or secondary, resulting from an excess of production or a defect of
renal elimination (renal calculus, leukaemias, cancer treatment,
nutritional defects, alcoholism).
Method
Enzymatic determination of uric acid using the following reactions
(Trinder method):
Uric acid + 2H2O + O2
Uricase
2H2O2 + 4AAP + EHSPT
Allantoin + CO2 + H2O2
Peroxidase
Mg++
Quinoneimine
(EHSPT = N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) n-Toluidine, 4 AAP = 4-aminoantipyrine)
Reagents
ABX Pentra Uric Acid CP is ready-to-use.
Reagent 1:
Form-0846 Rev. 2
Reagent 2:
Phosphate buffer, pH 7.00 125 mmol/l

EHSPT
1.38 mmol/l
Ascorbate oxidase
1100 U/l
Bovine albumin
0,2 %
Sodium azide
< 0,1 %
4-aminoantipyrine
1.8 mmol/l
Uricase
700 U/l
Peroxidase
7,500 U/l
Ferrocyanide
250 mol/l
Bovine albumin
0,2 %
Sodium azide
< 0,1 %
HORIBA ABX
BP 7290
Handling
Remove the caps of the cassette, place in the refrigerated ABX Pentra
Calibrator
Control
1 x 10 ml + 1 x 10 ml

ABX Pentra Uric Acid CP should be used according to this reagent

otherwise.
ABX Pentra
Uric Acid CP
Specimen
Serum
Plasma in heparin
Detection limit:
Reference range(8)
Serum, plasma: Women: 26
2.6
155
Men:
35
3.5
208
Urine:
60 mg/l
6 mg/dl
357 mol/l
72 mg/l
7.2 mg/dl
428 mol/l
250 - 750 mg/24h

1500 - 4500 mol/24h

range.

Pentra 400".
Assay Procedure
Waste Management
2. These reagents contain less than 0.1 % of sodium azide as a
form explosive metal azides, these reagents should be disposed of
by flushing with copious amounts of water.
General Precautions

Serum, Plasma

protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

275
692
150.5
272.5
427.8
CV %
0.5
0.3
1.2
0.9
1

Normal control
Specimen 1
Specimen 2
Mean value mol/l

275.9
698.1
277.6
400.9
CV %
2.78
1.38
2.63
2.49

Correlation:
Interferences:
Haemoglobin:
Triglycerides:
Total Bilirubin:
Direct Bilirubin:

Conversion factor:

ABX Pentra
Uric Acid CP
Correlation:
Y = 0.97 x + 37.2 with a correlation coefficient r = 0.999.
Application release : 4.xx
Conversion factor:
Urine


Detection limit:
Warning

protocol (4).
Normal control
Specimen 1
Specimen 2
Specimen 3
Mean value mol/l

712
484
486
1517
3660
CV %
2.4
3.0
3.3
2.2
0.8

Normal control
Specimen 1
Specimen 2
Mean value mol/l

724
530
1565
3804
CV %
4.13
4.36
2.84
2.41

Reference
1. Mazires B., Physiopathologie des hyperuricmies, Rev. Prat., 33,
43, (1983), 2231-2241.
2. Fossati,P., Prencipe,L. et Berti, G. Use of 3,5-dichloro-2-hydroxybenzenesulfonic acid 4-aminophenazone chromogenic system in
direct enzymatic assay of uric acid in serum and urine. Clin.Chem.
1980,26,227.
3. Tietz. Fundamentals of Clinical Chemistry.Chap.22.425-426(2001).
february 1999.
september 1986.
19, 2002.

High linearity: 14875 mol/l, with automatic post-dilution:
44625 mol/l.
a.Modification from index J to K: suppression of minor index.
b.Modification from index J to K: suppression of minor index.
ABX Pentra
Uric Acid CP
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ABX Pentra

ABX Pentra Albumin CP

Diagnostic reagent for quantitative in-vitro

HORIBA ABX SAS

The frequency of controls and the confidence intervals should

Automated clinical chemistry analyser

We recommended that each laboratory establishes its own reference

For calibration, use:

Storage and Stability

Materials required but not provided

For internal quality control, use:

Reagents, in unopened cassettes, are stable up to the expiry date on

Latest version documents on www.horiba.com

Performance on ABX Pentra 400

Mean value mol/l

Reproducibility (run-to-run precision)

Mean value mol/l

Linearity and Measuring Range:

No significant influence is observed up to 232 mol/l

a. Modification from index I to J: correction of conversion factor.

Latest version documents on www.horiba.com

8. Evaluation of the Linearity of Quantitative Analytical Methods,

Latest version documents on www.horiba.com

Latest version documents on www.horiba.com

ABX Pentra Bilirubin, Direct CP

Diagnostic reagent for quantitative in-vitro

Clinical Interest (1,2)

Materials required but not provided

a. Modification from index G to H: new handling.

Latest version documents on www.horiba-abx.com

Reference range (1)

Storage and Stability

Reproducibility (run-to-run precision)

Linearity and Measuring Range:

Performance on ABX Pentra 400

Mean value mol/l

Do not use haemolysed samples.

Number of tests: 100 tests

On board Reagent Stabilitya:

Sample volume: 25 l/test

The calibration stability is at least 10 days.

Mean value mol/l

a. Modification from index G to H: new on board reagent stability.

Note: A recalibration is recommended when reagent lots change, and

Latest version documents on www.horiba-abx.com

3. Rand R.N., di Pasqua A. A new diazo method for the determination

Latest version documents on www.horiba-abx.com

Latest version documents on www.horiba-abx.com

ABX Pentra Bilirubin, Total CP

Diagnostic reagent for quantitative in-vitro

Clinical Interest (1,2)

HORIBA ABX SAS

Materials required but not provided

Latest version documents on www.horiba.com

On board Reagent Stability:

Sample volume: 8 l/test

It is very important to store the sample protected from light!

Reference range (1)

Storage and Stability

Mean value mol/l

Reproducibility (total precision)

Please refer to local legal requirements.

Performance on ABX Pentra 400