Multicenter Evaluation of the Bayer ADVIA Centaur® HIV 1/O/2 Enhanced (EHIV) Assay

Joseph Schappert, Frank H. Wians Jr., Eugene Schiff, David Smalley, Ronald Gambardella, William M. Lee, Jiaxi Wu, Philip Keiser, Dolores Peterson, Maria De Medina, Lawrence Baker, Barbara Preisel-Simmons

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)158-166
Number of pages9
JournalClinica Chimica Acta
Volume372
Issue number1-2
DOIs
StatePublished - Oct 1 2006

Keywords

  • ADVIA Centaur
  • AIDS
  • Bayer
  • Clinical trial
  • HIV
  • Human immunodeficiency virus

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry

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    Schappert, J., H. Wians Jr., F., Schiff, E., Smalley, D., Gambardella, R., Lee, W. M., Wu, J., Keiser, P., Peterson, D., De Medina, M., Baker, L., & Preisel-Simmons, B. (2006). Multicenter Evaluation of the Bayer ADVIA Centaur® HIV 1/O/2 Enhanced (EHIV) Assay. Clinica Chimica Acta, 372(1-2), 158-166. https://doi.org/10.1016/j.cca.2006.04.017