Multicenter evaluation of the Bayer ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay.
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.
Schappert
Joseph
J
Department of Pathology and Laboratory Medicine, St. Luke's-Roosevelt Hospital Center, New York, NY 10025, USA.
Wians
Frank H
FH
Schiff
Eugene
E
Smalley
David
D
Gambardella
Ronald
R
Lee
William M
WM
Wu
Jiaxi
J
Keiser
Philip
P
Peterson
Dolores
D
De Medina
Maria
M
Baker
Lawrence
L
Preisel-Simmons
Barbara
B
D015492:AIDS Serodiagnosis / Q000379:methods*; D000465:Algorithms; D015153:Blotting, Western; D005260:Female; D015497:HIV-1 / Q000302:isolation & purification*; D015498:HIV-2 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity