Clinica chimica acta; international journal of clinical chemistry · 2006
Multicenter evaluation of the Bayer ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Schappert Joseph, Wians Frank H, Schiff Eugene, Smalley David, Gambardella Ronald, Lee William M, Wu Jiaxi, Keiser Philip, Peterson Dolores, De Medina Maria, Baker Lawrence, Preisel-Simmons Barbara
Аннотация
BACKGROUND: It is important that serological assays detect antibodies to human immunodeficiency virus (HIV) in all infected individuals, including those infected with less prevalent, more diverse subtypes.
METHODS: Performance of the ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay was tested on 1344 samples from HIV-positive subjects, 6061 samples from groups at low-risk for HIV infection, and 1042 samples from groups at high-risk for HIV-1 and HIV-2 infection. Results were compared with those of an FDA-approved predicate assay.
RESULTS: The ADVIA Centaur EHIV Assay showed good precision with a diagnostic specificity of 99.9% and diagnostic sensitivity of 100%. HIV seroconversion was detected earlier in 6 panels, at the same time in 13 panels and later in only 1 of the panels when compared to the predicate assay, thereby narrowing the window period between infection and antibody detection. Of clinical significance, a blood donor sample that was indeterminate by HIV-1 Western blot and non-reactive by the predicate assay was repeatedly reactive in the ADVIA Centaur Assay and confirmed as positive by HIV-2 immunoblot.
CONCLUSIONS: The ADVIA Centaur EHIV Assay is useful as an aid in the diagnosis of individuals infected with HIV-1 and/or HIV-2.
METHODS: Performance of the ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay was tested on 1344 samples from HIV-positive subjects, 6061 samples from groups at low-risk for HIV infection, and 1042 samples from groups at high-risk for HIV-1 and HIV-2 infection. Results were compared with those of an FDA-approved predicate assay.
RESULTS: The ADVIA Centaur EHIV Assay showed good precision with a diagnostic specificity of 99.9% and diagnostic sensitivity of 100%. HIV seroconversion was detected earlier in 6 panels, at the same time in 13 panels and later in only 1 of the panels when compared to the predicate assay, thereby narrowing the window period between infection and antibody detection. Of clinical significance, a blood donor sample that was indeterminate by HIV-1 Western blot and non-reactive by the predicate assay was repeatedly reactive in the ADVIA Centaur Assay and confirmed as positive by HIV-2 immunoblot.
CONCLUSIONS: The ADVIA Centaur EHIV Assay is useful as an aid in the diagnosis of individuals infected with HIV-1 and/or HIV-2.