Comparison of 4th-generation HIV antigen/ antibody combination assay with 3rd-generation HIV antibody assays for the occurrence of false-positive and false-negative results

Alagarraju Muthukumar, Adnan Alatoom, Susan Burns, Jerry Ashmore, Anne Kim, Brian Emerson, Edward Bannister, M. Qasim Ansari

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

Objective: To assess the false-positive and false-negative rates of a 4th-generation human immunodeficiency virus (HIV) assay, the Abbott ARCHITECT, vs 2 HIV 3rd-generation assays, the Siemens Centaur and the Ortho-Clinical Diagnostics Vitros. Methods: We examined 123 patient specimens. In the first phase of the study, we compared 99 specimens that had a positive screening result via the 3rd-generation Vitros assay (10 positive, 82 negative, and 7 indeterminate via confirmatory immunofluorescent assay [IFA]/ Western blot [WB] testing). In the second phase, we assessed 24 HIV-1 RNA-positive (positive result via the nuclear acid amplification test [NAAT] and negative/indeterminate results via the WB test) specimens harboring acute HIV infection. Results: The 4th-generation ARCHITECT assay yielded fewer falsepositive results (n = 2) than the 3rd-generation Centaur (n = 9; P = .02) and Vitros (n = 82; P <.001) assays. One confirmed positive case had a false-negative result via the Centaur assay. When specimens from the 24 patients with acute HIV-1 infection were tested, the ARCHITECT assay yielded fewer false-negative results (n = 5) than the Centaur (n = 10) (P = .13) and the other 3rd-generation tests (n = 16) (P = .002). Conclusions: This study indicates that the 4th-generation ARCHITECT HIV assay yields fewer false-positive and false-negative results than the 3rd-generation HIV assays we tested.

Original languageEnglish (US)
Pages (from-to)84-89
Number of pages6
JournalLab Medicine
Volume46
Issue number2
DOIs
StatePublished - May 1 2015

Keywords

  • 3rd-generation HIV assays
  • 4th-generation HIV testing
  • False-negative results
  • False-positive results
  • HIV
  • Western blot

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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