Professional Documents
Culture Documents
Test results should be read within 15 minutes once the specimen has been placed in the test well. Our Chlamydia Rapid Tests are limited to the qualitative detection of Tp antibodies in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information available to the physician. NEGATIVE RESULT: If only the C band has developed the test indicates that no detectable Chlamydia antibodies are present in the specimen. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of Chlamydia antibodies in the specimen. Positive tests must be confirmed by a qualified medical practitioner. INVALID: If no control band has developed, the essay is invalid regardless of color development on the test band as indicated above. Repeat the assay with a new kit. NOTE: The intensity of the color in the test region (T) varies with the concentration of Chlamydia antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. A false negative result can occur if the quantity of the antibodies to Chlamydia present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. A negative result for an individual subject indicates absence of detectable antibodies to Chlamydia at the time of testing, but does not completely preclude the possibility of infection with the disease. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC.
3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the specimen well of the test device and start the timer. 5. Wait for the rose-pink line (S) to appear. The result should be read at 10-15 minutes, but must not be read if more than 20 minutes has elapsed since testing.
TEST LIMITATIONS 1. Our (Tp) Combo (WB/P/S) Rapid Tests are limited to the qualitative detection of Tp antibodies in whole human blood, serum or plasma. 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician. 4. A false negative result can occur if the quantity of the antibodies to Tp present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. 5. A negative result of an individual subject indicates absence of detectable antibodies to syphilis at the time of testing, but does not completely preclude the possibility of infection with the disease. INTENDED USE Our Syphilis Rapid Tests detects Tp antibodies to the syphilis virus in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s). PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 20 minutes once the specimen has been placed in the test well. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY The Std tests R Us Syphilis (Tp) kit permits the detection of antibodies to syphilis. The test is able to detect antibodies during both the active and dormant phases of the disease. This test is intended for home use. Positive tests must be confirmed by a qualified medical practitioner.
1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable Tp antibodies are present in the specimen. 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of Tp antibodies in the specimen. Positive results should be confirmed with alternative testing method(s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of Tp antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.
3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the S well of the cassette and immediately add 1-2 drops of the specimen buffer into the S well too. 5. Depending on the blood concentration of HbsAg, positive result may be observed in as little as 60 seconds. The result should be read at 10 minutes, but must not be read if more than 20 minutes has elapsed since testing
TEST LIMITATIONS 1. Our HBsAg (WB/P/S) Rapid Test is limited to the qualitative detection of HBsAg in whole human blood, serum or plasma 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician 4. A false negative result can occur if the quantity of the antibodies to hepatitis B virus (HBV) present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected 5. A negative result of an individual subject indicates absence of detectable antibodies to HBV at the time of testing, but does not completely preclude the possibility of infection with HBV. INTENDED USE Our HBsAg Rapid Test detects HBsAg antibodies to Hepatitis B in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s).
1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HBsAg antibodies are present in the specimen 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HBsAg antibodies in the specimen. Positive results should be confirmed with alternative testing methods (s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HBsAg antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.
PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 15 minutes once the specimen has been placed in the test well. 3. Negative results must be allowed to develop for 30 minutes to ensure that the kit is functioning correctly. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY Hepatitis B virus affects the liver and is transmitted by sexual activity; blood borne exposure, and other routes. It causes liver damage including acute self-limiting infection, fulminating hepatitis and chronic carrier state. The Std Tests R Us HBsAg kit permits the detection of HBsAg which appears 1-7 weeks before liver jaundice can be detected. Positive tests must be confirmed by a qualified medical practitioner.
3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the S well of the cassette and immediately add 1-2 drops of the specimen buffer into the S well too. 5. Depending on the blood concentration of HCV, positive result may be observed in as little as 60 seconds. The result should be read at 10 minutes, but must not be read if more than 20 minutes has elapsed since testing.
TEST LIMITATIONS 1. Our HCV (WB/P/S) Rapid Test is limited to the qualitative detection of HCV in whole human blood, serum or plasma 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician 4. A false negative result can occur if the quantity of the antibodies to hepatitis C virus (HCV) present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected 5. A negative result of an individual subject indicates absence of detectable antibodies to HCV at the time of testing, but does not completely preclude the possibility of infection with HCV. INTENDED USE Our HCV Rapid Test detects HCV antibodies to Hepatitis C in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s).
1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HCV antibodies are present in the specimen. 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HCV antibodies in the specimen. Positive results should be confirmed with alternative testing methods (s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HCV antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.
PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 15 minutes once the specimen has been placed in the test well. 3. Negative results must be allowed to develop for 30 minutes to ensure that the kit is functioning correctly. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY Hepatitis C virus affects the liver and is transmitted by sexual activity; blood borne exposure, and other routes. It causes liver damage including acute self-limiting infection, fulminating hepatitis and chronic carrier state. The Std Tests R Us HCV kit permits the detection of HCV which appears 1-7 weeks before liver jaundice can be detected. Positive tests must be confirmed by a qualified medical practitioner.
The Std Tests R Us HIV (WB/P/S) Rapid Test is limited to the qualitative detection of HIV antibodies in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information. A false negative result can occur if the quantity of HIV antibodies present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. A negative result for an individual subject indicates absence of detectable antibodies to HIV at the time of testing, but does not completely preclude the possibility of infection. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HIV antibodies are present in the specimen. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HIV antibodies in the specimen. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HIV antibodies present in the specimen. Therefore, any detectable color in the test region should be considered as a positive result. INVALID: If no C band has developed, the essay is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new kit. PRECAUTIONS The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. Test results should be read within 15 minutes once the specimen has been placed in the test well. TEST DETAILS The Std Tests R Us HIV (Type 1 and 2) (WB/P/S) test cassette comprises 1) a pink colored conjugate pad containing anti-HIV antibodies conjugated with colloid gold (HIV conjugated) and rabbit lgG-gold, 2) a nitrocellulose membrane strip containing test and control bands. The T band is coated with non-conjugated Tp antibodies whereas the C band is coated with goat anti-rabbit lgG. The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the specimen, antibodies present in the sample will move across the conjugate pad under capillary action. The immune-complex is then captured on the membrane, forming a pink rose-colored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit. SUMMARY The Human immunodeficiency virus (Type 1 and 2) are enveloped, single strain RNA positive viruses. HIV infection may lead to Acquired Immuno-deficiency disease (AIDS) The Std Tests R Us HIV (Type 1 and 2) Rapid Test (WB/P/S) is a rapid test that qualitatively detects the presence of antibodies to HIV 1 and/or HIV 2 in whole blood, serum or plasma. Positive tests must be confirmed by a qualified medical practitioner.
PRECAUTIONS The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date.
Test results should be read within 15 minutes once the specimen has been placed in the test well. The Std Tests R Us Gonorrhea Rapid Test is limited to the qualitative detection of Neisseria Gonorrhoeae in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information available to the physician A false negative result can occur if the quantity of the antibodies to Gonorrhea present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected A negative result for an individual subject indicates absence of detectable antibodies to Gonorrhea at the time of testing, but does not completely preclude the possibility of infection with the disease STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC.
NEGATIVE RESULT: If only one colored band appears (the control band) the test indicates that no detectable Neisseria Gonorrhea antibodies are present in the specimen. POSTIVE RESULT: If a second pink band appears (two bands), the test indicates the presence of Neisseria Gonorrhea antibodies in the specimen. INVALID: If no control band has developed, the essay is Invalid regardless of color development on the test band as indicated above. Repeat the assay with a new kit TEST PRINCIPLE The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the specimen, antibodies (IgG, IgM, or IgA) present in the sample will move across the conjugate pad under capillary action. The immunocomplex is then captured on the membrane, forming a pink rosecolored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit.