A rapid test for the diagnosis of Human Immunodeficiency Virus.
The HIV 1/2/O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus(HIV) type 1,type 2 and subtype O in whole blood, serum or plasma to aid in the diagnosis of HIVinfection. The HIV 1/2/O Rapid Test cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of the HIV 1/2/O Rapid Test cassette (Whole Blood/Serum/Plasma) is >99.9%, and the relative specificity is 99.9%.
Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Place the cassette on a clean and level surface. For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma to the specimen area, then add 1 drop of buffer, and start the timer. For Whole Blood specimen: Hold the dropper vertically and transfer drops of whole blood to the specimen area, then add 2 drops of buffer and start the timer. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Do not use after expiration date. Do not eat, drink or smoke in the area where the specimens or test cassettes are handled. Do not use test if pouch is damaged. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. The used test should be discarded according to local regulations. Humidity and temperature can adversely affect results.
Posittive: Two or three distinct colored lines appear. One line should always appear in the control line region (C), and another one or two apparent colored line(s) should appear in the test line region(s) (T1 and/or T2). Please note that the intensity of the color in the test line region (T1 and T2) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test line region (T1 and/or T2) should be considered positive. Negative: One colored line appears in the control region (C). No apparent colored lines appear in the test line regions (T1 and T2). Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device.
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze. Do not use after the expiration date.
The information presented at the site has a general character. Note please this information cannot be used for self-treatment and self diagnosis. You should consult with your doctor or health care adviser regarding any specific instructions of your condition. The information is reliable, but we concede it could contain mistakes. We are not responsible for any direct, indirect, special or other damage caused by use of this information on the site and also for consequences of self-treatment.