TY - JOUR
T1 - 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
AU - Muthukumar, Alagarraju
AU - Alatoom, Adnan
AU - Burns, Susan
AU - Ashmore, Jerry
AU - Kim, Anne
AU - Emerson, Brian
AU - Bannister, Edward
AU - Ansari, M. Qasim
PY - 2015/5/1
Y1 - 2015/5/1
N2 - 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.
AB - 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.
KW - 3rd-generation HIV assays
KW - 4th-generation HIV testing
KW - False-negative results
KW - False-positive results
KW - HIV
KW - Western blot
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U2 - 10.1309/LMM3X37NSWUCMVRS
DO - 10.1309/LMM3X37NSWUCMVRS
M3 - Article
C2 - 25918186
AN - SCOPUS:84946843490
SN - 0007-5027
VL - 46
SP - 84
EP - 89
JO - Lab Medicine
JF - Lab Medicine
IS - 2
ER -