Evaluation of a new HIV-1/HIV-2 assay.

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Evaluation of a new HIV-1/HIV-2 assay.

Abstr Gen Meet Am Soc Microbiol. 1994;94:554 (abstract no. C-363). Unique Identifier : AIDSLINE ASM94/94313104
Betlach B; Hanson M; Valinsky J; Sacramento Medical Foundation Center for Blood Research, CA.

Abstract: Three blood donor sites in the United States evaluated a new MicroTrak II enzyme immunoassay pending FDA approval for the detection of antibodies to HIV-1 and/or HIV-2. It was compared with licensed reference assays. Fresh samples from 10,468 volunteer blood donors, and 417 archival frozen samples positive for HIV-1 antibodies were tested. The MicroTrak II assay had a sensitivity of 99.76% on the HIV-1 positive samples. One sample that tested negative was collected in 1988, had been subjected to several freeze-thaw cycles and was visually cloudy. This sample is undergoing further evaluation. The specificity of the blood donor samples was 99.86%. TABULAR DATA, SEE ABSTRACT VOLUME. The MicroTrak II anti-HIV 1/2 assay has equivalent sensitivity and specificity to currently licensed methods except for one tested sample undergoing further evaluation.

Keywords: Acquired Immunodeficiency Syndrome/*DIAGNOSIS/PREVENTION & CONTROL *Blood Donors Comparative Study Human HIV Antibodies/*BLOOD HIV Seropositivity/*DIAGNOSIS HIV-1/*ISOLATION & PURIF HIV-2/*ISOLATION & PURIF Reference Standards Sensitivity and Specificity United States ABSTRACT
941030
M94A0850

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