HIV Triline Test

**Caution: This product is not 510(k) cleared by US FDA and thus is not for sale in the United States.**
QuickProfile™ HIV I & II Triline Test Card is a single use, rapid test device, double antigen sandwich immunoassay for qualitative detection of antibodies to Human Immunodeficiency Viruses or HIV I&II in serum, plasma or whole blood. It is intended for medical institution as the aid for the diagnosis of possible HIV infection. The product may be used for the quick screening of blood donors and blood products.
SUMMARY AND EXPLANATION
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 state, 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 in blood of individuals suspected of HIV infection. Antigen can generally be detected during the acute phase and during the symptomatic phase of AIDS only. Antibodies to HIV-1 and/or HIV-2 may 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.
PRINCIPLE OF THE ASSAY
QuickProfile™ HIV I & II Triline Test Card 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 and HIV-2 antigens are bond at the Test Zones 1 and 2 respectively and rabbit anti-HIV 1+2 antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV-1 and/or HIV-2 antibodies in sample, they will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone 1 and/or 2 where they are captured by the HIV -1 and /or HIV-2 antigens generating a visible red line. It indicates a positive result that a red line appears at zone 1 and /or zone 2. If there are no HIV 1 or HIV 2 antibodies in sample, no red line is formed in the Test Zones,which indicates a negative result.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.