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- Title
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.
- Authors
Muthukumar, Alagarraju; Alatoom, Adnan; Burns, Susan; Ashmore, Jerry; Kim, Anne; Emerson, Brian; Bannister, Edward; Ansari, M. Qasim
- 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 false- positive 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.
- Subjects
COMPARATIVE studies; DIAGNOSTIC errors; FLUORESCENT antibody technique; PROBABILITY theory; STATISTICAL sampling; WESTERN immunoblotting; DATA analysis; EVALUATION research; CONTINUING education units; RETROSPECTIVE studies; AIDS serodiagnosis; NUCLEIC acid amplification techniques
- Publication
Laboratory Medicine, 2015, Vol 46, Issue 2, p84
- ISSN
0007-5027
- Publication type
Article
- DOI
10.1309/LMM3X37NSWUCMVRS