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Clinical Chemistry 35: 946-952, 1989;
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Clinical Chemistry, Vol 35, 946-952, Copyright © 1989 by American Association for Clinical Chemistry

Development of a confirmatory enzyme-linked immunosorbent assay for HIV- 1 antibodies

CS Chiang, T Grove, M Cooper, J Cuan, A Kowalski, K Parcells, M Tsunokawa, M Rosenberg, E Arcuri and S Franklin
SmithKline Bio-Science Laboratories, Van Nuys, CA 91405.

We subcloned six discrete protein-coding regions representing the gag (Kp24 and Kp55), env (Kp41, Kp120N, and Kp120CC), and pol (Kp66/31) gene products of the human immunodeficiency virus type 1 (HIV-1) and expressed them in Escherichia coli as fusion proteins with the first 56 residues of galactokinase. An enzyme-linked immunosorbent assay for confirming the presence of HIV-1 antibodies was developed by coating the six purified antigens on individual wells of a microtiter plate (the HIVAGEN assay). This assay yielded no false-negative results and fewer indeterminate results than the Western blot assay for 143 specimens from patients with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC). Analysis of 1016 specimens from seronegative donors by the HIVAGEN assay yielded no false-positive results, and the rate of indeterminate results was substantially lower than for the Western blot assay. The HIVAGEN assay is well suited for routine confirmation of the presence of HIV-1 antibodies because it is objective, quantitative, rapid, precise, and readily automatable.


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S. Hashida, S. Ishikawa, K. Hashinaka, I. Nishikata, S. Oka, and E. Ishikawa
Earlier Detection of Human Immunodeficiency Virus Type 1 p24 Antigen and Immunoglobulin G and M Antibodies to p17 Antigen in Seroconversion Serum Panels by Immune Complex Transfer Enzyme Immunoassays
Clin. Vaccine Immunol., November 1, 2000; 7(6): 872 - 881.
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