Intended Use
The Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 from KHB is an in vitro, visually
read test for the qualitative determination of antibodies against HIV-1 and HIV-2 in human
serum, plasma, venous and capillary whole blood. This product is intended for use as an aid
to detect antibodies against HIV (1+2) from individuals suspected to be infected by HIV.
It is intended to be used by laboratory professional and health care workers at
point-of-care.
Summary and Explanation of the Test
AIDS (Acquired Immunodeficiency Syndrome) is an immunosuppressive disease
characterized by depletion of the helper T-cell, which leaves the infected individual
susceptible to opportunistic infections and some malignancies. Viruses that have been
detected to cause AIDS are HIV-1, first isolated in 1983 (1) and HIV-2, a distinctive but
related type isolated in 1985. Presence of the virus elicits the production of the antibodies
specific to either HIV-1 or HIV-2, and this test is designed to detect the antibodies to
indicate the presence of HIV infection.
Principle of the Procedure
The Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 from KHB adopts the solid
phase colloidal gold immunochromatographic technology for the qualitative detection of
antibodies against HIV-1/HIV-2. The gold HIV-1 gp160(2) conjugate and the gold HIV-2 gp36(3)
conjugate are coated to the conjugate pad in advance. The test line (recombinant gp36 and
gp41 antigens) and the control line (monoclonal antibody against gp160) are pre-coated on
the surface of Nitrocellulose (NC) membrane. When the specimen is added to the sample
pad, it migrates through the conjugate pad, reconstitutes and mixes with the colloidal
gold-antigen complex and moves on till the end of the strip. A reddish-purple test line will
be visible in the strip if there are enough antibodies against HIV-1/HIV-2 in the specimen. If
the specific antibodies are absent, or present at a very low level, no test line appears (4, 5).