UBI® HIV -1/2 EIA

DIRECTION INSERT
WHO Report 9 /10, GENEVA January 1998

The UBI® HIV-1/2 EIA test is an enzyme-linked immunosorbent assay for the qualitative detection of circulating antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and to Human Immunodeficiency Virus Type 2 (HIV-2) in human serum or plasma. The in vitro diagnostic test is based on immunosorped synthetic peptides to the core and envelope proteins of the HIV-1 and HIV-2 viruses on a 96-well microtiter plate. The kit was licensed by the US FDA in 1996 and is indicated as a diagnostic test as an aid in the diagnosis of potential infection with HIV-1 and/or HIV-2.

This test has been used in WHO sponsored surveillance programs in India and Africa. It is based on the UBI® HIV-1 EIA that was licensed by the US FDA in 1989 and is the first peptide-based diagnostic test the FDA recognized.

The unique use of synthetic peptide antigens in the UBI® HIV-1/2 EIA provides UBI with distinct product development advantages for modification of next generation HIV immunodiagnostics.

This screening test, with a total incubation time of 60 minutes, is a fast, easy to use OPD-substrate based EIA. Total run time is generally less than 2 hours and allows rapid daily sample throughput. The test is compatible with many automated sample handling systems such as the Hamilton AT series and other open systems.

The UBI® HIV-1/2 EIA test is licensed for use with fresh or frozen sera and plasma. The sample is diluted 1:21 in a sample diluent on the antigen-coated microplate wells, incubated for 30 minutes at 37°C, and washed with a saline-based buffer. A dilute solution of HRP-conjugated anti-Human IgG is added to the microplate wells, incubated for 15 minutes at 37°C, and is washed again. The OPD substrate is provided as individual easy to store and to handle foil-wrapped tablets that easily dissolves in the substrate diluent. After the OPD solution is added to the microplate wells, the plate has a final 15 minute incubation at 37°C. A dilute solution of 1 molar sulfuric acid is added to the microplate wells to halt the OPD-HRP reaction. The microplate may be read at 490 nm to obtain absorbance values to calculate a relative signal-to-cutoff ratio based on the absorbance of the positive control sera provided in the kit. Those wells which are yellow-orange reflect the colorimetric reaction of the antigen-antibody-HRP-OPD complex that indicates the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and to Human Immunodeficiency Virus Type 2 (HIV-2) in the test sample.

Product Specifications
Catalog # 600441, UBI® HIV-1/2 EIA kit, 192 tests
The shelf life of the UBI® HIV-1/2 EIA kit is 15 months when stored at 2 - 8牵C

The UBI® HIV-1/2 EIA kit is provided in convenient modular microplate strip plates to accommodate small volume users such as hospitals and clinics as well as higher throughput blood banks or reference laboratories.

Primary packaging emphasizes safety to the end-user while meeting all shipping safety requirements. Secondary packaging is completely recyclable and bio-degradable.

The UBI® HIV-1/2 EIA may be used on any open sample handling system and with any incubation system – convection air, static air or water bath. The test may be easily performed for as few as two test samples and as many as 88 test samples per microplate.