title: Development of a new less-sensitive enzyme immunoassay for detection of early HIV-1 infection.
abstract: The sensitive/less-sensitive (S/LS) enzyme immunoassay (EIA) testing strategy for discriminating "early" from "longstanding" HIV infection has been widely applied for detecting recent seroconverters and estimating HIV incidence rates. The originally developed assay (3A11-LS EIA; Abbott Laboratories, Abbott Park, IL) involved performance of LS EIAs using a bead-based assay that required specialized equipment and reagents of limited availability. In contrast, 96-microwell-based EIAs are more universally applied for HIV serodiagnosis throughout the world. The authors report development and preliminary validation of an LS protocol using an EIA in a 96-well format: the Vironostika HIV-1 MicroElisa System (Vironostika-LS EIA; Bio Merieux, Raleigh, NC). The results with samples from recent HIV-1 seroconverters, persons with longstanding HIV-1 asymptomatic infection, patients on highly active antiretroviral therapy, and AIDS patients show a high degree of correlation between the Vironostika-LS EIA and 3A11-LS EIA. The authors also demonstrate that the Abbott 3A11-LS EIA and Vironostika-LS EIA performed comparably on HIV-1-positive samples from persons infected with non-B HIV-1 subtypes. These results support the potential use of the Vironostika-LS EIA for detection of recent HIV-1 infections for incidence projections and for other epidemiologic, clinical, and molecular surveillance applications.
authors.affiliation: Blood Centers of the Pacific, San Francisco, California 94118, USA.
authors.forename: Bhupat D
authors.initials: BD
authors.lastname: Rawal
authors.forename: Azucena
authors.initials: A
authors.lastname: Degula
authors.forename: Ludmila
authors.initials: L
authors.lastname: Lebedeva
authors.forename: Robert S
authors.initials: RS
authors.lastname: Janssen
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Hecht
authors.forename: Haynes W
authors.initials: HW
authors.lastname: Sheppard
authors.forename: Michael P
authors.initials: MP
authors.lastname: Busch
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis / Q000276:immunology / Q000821:virology; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology*; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D008297:Male; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies