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Performance Characteristics of a New Less Sensitive HIV-1 Enzyme Immunoassay for Use in Estimating HIV Seroincidence

Kothe Denise; Byers, Robert H.; Caudill, Samuel P.; Satten, Glen A.; Janssen, Robert S.; Hannon, Harry W.; Mei, Joanne V.
JAIDS Journal of Acquired Immune Deficiency Syndromes: August 15th, 2003

Less sensitive (LS) HIV-1 enzyme immunoassays (EIAs) have significantly improved the quantity and quality of HIV surveillance data. The first LS-HIV-1 EIA, the Abbott 3A11-LS, provided reliable incidence data, but the assay required specialized equipment, and the lack of available reagents made testing difficult. This study evaluated the use of an alternate assay, a modified version of the Vironostika HIV-1 EIA (Vironostika-LS), to be used for LS testing. The Vironostika-LS has similar performance characteristics to the Abbott 3A11-LS with additional advantages. This 96-well formatted assay is commonly found in public health laboratories for routine HIV-1 testing and can be used with both serum and dried blood spot specimens. The estimated mean time from seroconversion (defined using a standardized optical density cutoff of 1.0) with the Vironostika-LS was 170 days (95% CI, 145-200 days). When the Vironostika-LS was applied to a matched serum set previously tested with the Abbott 3A11-LS, the Vironostika-LS accurately identified 97% of specimens with recent or long-standing HIV infection. The paper also reports Vironostika-LS quality control guidelines and the results from 3 rounds of proficiency testing.

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Denise Kothe is an ORISE Fellowship Recipient, Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee.

Address correspondence and reprint requests to Joanne Mei, Newborn Screening Branch, Division of Laboratory Sciences, National Center for Environmental Health, 4770 Buford Highway NE, MS F-19, Atlanta, GA 30341-3717. E-mail:

Manuscript received February 2, 2003; accepted May 13, 2003.

© 2003 Lippincott Williams & Wilkins, Inc.