Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.
SUITABILITY OF RECOMBINANT ANTIGENS AND A SYNTHETIC PEPTIDE AS HUMAN IMMUNODEFICIENCY VIRUS DIAGNOSTIC REAGENTS
HIV Detection by Genetic Engineering Methods. Luciw PA and Steimer KS, eds. New York, Marcel Dekker, p. 99-120, 1989.. Unique Identifier : AIDSLINE ICDB/90660257 Shoeman RL; Khan FR; Heimer EP; Crowl RM; Pottathil R; Roche Res. Center, Hoffmann-La Roche Inc., Nutley, NJ
Abstract:
A critical need exists for sensitive diagnostic reagents to detect not only antibodies to HIV in blood and organ donors but also to detect the virus directly. The production, purification, and ELISAs are reviewed for four recombinant HIV antigens and a synthetic HIV env peptide. In addition, data are presented from a large-scale study comparing the most promising ELISA assays with commercial HIV-diagnostic kits. Performance of ELISA assays based on a gag/env fusion protein and the env peptide is evaluated critically using results obtained with a select panel of well-characterized human sera. The novel recombinant gag/env fusion protein, as well as the synthetic HIV env (578-608)-NH2 peptide, had sensitivities (99.5% and 99.8%, respectively) approaching that of viral protein-based commercial kits (100%), while displaying clearly superior specificities (99.1% and 99.3% versus 92.9%). The recombinant HIV gag/env protein-based ELISA had markedly improved specificity relative to the recombinant HIV gag protein-based ELISA. However, the recombinant HIV gag/env protein-based ELISA failed to detect 3/597 positive sera samples in large-scale screening. Using a select panel of problem human sera, the sensitivity and specificity of the ELISA assay based on the recombinant HIV gag/env protein dropped to 45% and 76%, respectively. In contrast, the sensitivity and specificity of the commercial kits for these sera were 100% and 50%, respectively. A surprising result of these studies was the overall excellent performance of the ELISAs based on the synthetic HIV env (578-608)-NH2 peptide. In screening both large-scale and problem samples, this assay was equal to or superior to the recombinant HIV protein assays. This suggests that gag determinants are not required to unequivocally identify HIV antibody-positive sera. The gag determinants employed here seemed to detract from the specificity of these assays because of cross-reactivity present in some negative sera, without any significant increase in sensitivity. The sensitivity of the synthetic HIV env (578-608)-NH2 peptide is clearly superior to that of a previously described env 579-599 peptide. It is plausible that a slightly larger synthetic env peptide or recombinant protein encompassing this region may be the best candidate for use as a diagnostic reagent for HIV antibodies. (42 Refs)
Keywords: AIDS Serodiagnosis/*METHODS *Cloning, Molecular Enzyme-Linked Immunosorbent Assay Gene Expression Regulation, Viral Gene Products, gag/GENETICS Human HIV/*GENETICS/IMMUNOLOGY HIV Antibodies/ANALYSIS HIV Antigens/*GENETICS HIV Infections/*DIAGNOSIS/PREVENTION & CONTROL Immunoblotting Mass Screening Viral Envelope Proteins/GENETICS MONOGRAPH REVIEW
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Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.
