HIV 1/2 Rapid Test Kit Background Information
The Human Immunodeficiency Viruses type 1 and type 2 are etiological agents of the acquired immunodeficiency syndrome (AIDS). HIV has been isolated from patients with AIDS, AIDS related complex (ARC) and from healthy individuals at high risk for (AIDS). Infection with HIV is followed by an acute flu-like illness. This phase may remain unnoticed and the relationship to HIV infection may not be clear in many cases. The acute phase is typically followed by an asymptomatic carrier, which progresses to clinical AIDS in about 50% of infected individuals within 10 years after seroconversion. Serological evidence of HIV infection may be obtained by testing for HIV antigens or antibodies. Antigen to HIV can be detected throughout virtually the total infection period, starting at or shortly after the acute phase and lasting until the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection.
HIV 1/2 Rapid Test Principle
This HIV (1+2) rapid test device employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 gp120, gp41 and HIV-2 gp-36 are dry-immobilized at the end of nitrocellulose membrane strip. HIV 1+2 antigens are bond at the Test Zone (T) and rabbit anti-HIV 1+2 monoclonal antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HIV ˝ antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HIV 1+2 antigens generating a visible red line. If there are no HIV 1 or 2 antibodies in sample, no red line is formed in the Test Zone (T).The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1+2 antibodies aggregating in a red line, which indicates the validity of the test.
HIV 1/2 Rapid Test Kit Performance and Characteristics
In a clinical evaluation of the performance of Diagnostic Automation, Inc. HIV 1/2 Rapid Test using 2657 confirmed negative and 667 positive samples, the resuls are as follow:
Sensitivity 99.4% (666/667)
Specificity 100% (2657/2657)
Overall agreement 100% with reference ELISA tests
Limitations of HIV 1/2 Rapid Test Kit
1. Negative results do not exclude the possibility of HIV exposure or infection. Infection through recent exposure (seroconversion) to HIV may not be detectable. A test giving an invalid result should be repeated. This HIV (1+2) Rapid Test does not differentiate between recognition of HIV-1 and HIV-2 antibodies.
2. If after retesting of the initially reactive samples, the test results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive rapid diagnostic tests, false positive results can occur due to the several reasons, most of which are related but not limited to the quality of the sample and exposure of the test to humidity. Please contact Diagnostic Automation technical support for further assistance 818-591-3030.
Diagnostic Automation Inc. also provides other Rapid Test Kits: