Chetty C, Holody, T, Olsen D, Jones G, Reddington K, Adamik, M, and Witt, D bioMérieux, Inc, Durham, NC
The Vironostika® HIV-1 Plus O Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), including Group O, in human specimens collected as serum, plasma, or dried blood spots. The Vironostika HIV-1 Plus O Microelisa System is intended for use as an aid in diagnosis of infection with HIV-1 and not for use in screening blood donors. This assay uses three solid phase antigens; inactivated, purified HIV-1 viral lysate proteins, a purified viral envelope protein (native gp160), and a synthetic peptide with an amino acid sequence corresponding to that of the transmembrane immunodominant domain of the HIV-1 Group O (ANT 70) isolate. Antibody to HIV-1 is captured to a microwell containing antigens, reacted with anti-human immunoglobulin (goat) conjugated with horseradish peroxidase (HRP) to form an immune complex, and detected with ABTS (2,2′-azino-di-[3-ethylbenzthiazoline-6-sulfonate]) substrate. The assay design sought to improve overall sensitivity to Group O while maintaining the specificity compared to the current licensed Vironostika HIV-1 (licensed comparator = LC) and to improve ease of use with a Sample Addition Monitoring and Color Coded Reagents. In clinical evaluation, the clinical sensitivity of the Vironostika HIV-1 Plus O was demonstrated with matched serum/plasma specimens and dried blood spot specimens collected from 1,010 HIV-1 infected individuals with various CD4+ counts; all specimens were repeatedly reactive with the assay and subsequently confirmed with Western blot. For twelve (12) seroconversion panels tested and compared to the LC, the Vironostika HIV-1 Plus O detected HIV-1 antibodies earlier than the LC test in each case. Detection of HIV-1 Group M antibodies was demonstrated with subtypes A, B, B/D, C, C/E, D, E, E/A, E/C, E/F, F, G and H. The assay exhibited higher analytical sensitivity with dilutional panels from clinical specimens for both HIV-1 Group M and HIV-1 Group O specimens compared to the LC. The results of the study indicate an enhanced detection of HIV-1 antibodies with the Vironostika HIV-1 Plus O assay.
Last Update: April 8, 2005