TY - JOUR
T1 - Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens
AU - Qiu, Xiaoxing
AU - Sokoll, Lori
AU - Yip, Paul
AU - Elliott, Debra J.
AU - Dua, Renu
AU - Mohr, Phaedre
AU - Wang, Xiao Yan
AU - Spencer, Megan
AU - Swanson, Priscilla
AU - Dawson, George J.
AU - Hackett, John
N1 - Funding Information:
This study was funded by Abbott Laboratories.
Publisher Copyright:
© 2017 The Author(s)
PY - 2017/7
Y1 - 2017/7
N2 - Background HIV Ag/Ab combination assays are recommended by CDC for routine screening and several HIV Ag/Ab combination tests are now FDA-approved. Maintaining high specificity and consistent sensitivity across diverse HIV strains is critical for these assays to accurately detect HIV infection and expedite delivery of patient results. Objectives To evaluate performance of three FDA-approved HIV tests: ARCHITECT HIV Combo (Abbott), ADVIA Centaur HIV Combo (Siemens) and BioPlex HIV Ag-Ab (Bio-Rad). Study design Sensitivity and specificity were evaluated using an extensive panel of 28 HIV infected human specimens and 17 cultured virus isolates representing multiple genotypes, 6 seroconversion panels, 4 human samples with acute infection, WHO p24 standard and 4020 clinical specimens. Results The p24 limit of detection (LOD) for the WHO standard was 0.19 IU/ml, 0.70 IU/ml, and 1.77 IU/ml in BioPlex, ARCHITECT, and Centaur respectively. The distribution of LODs across 15 HIV-1 isolates was substantially narrower in ARCHITECT (5–33 pg/ml) than in BioPlex (11–198 pg/ml) and Centaur (6–384 pg/ml). All assays detected antibodies to the majority of HIV-1 and HIV-2 variants. However, reduced sensitivity was observed for Centaur in detection of antibodies to HIV-1 group M (CRF02_AG), O and N variants. BioPlex and ARCHITECT showed better seroconversion sensitivity than Centaur, detecting one bleed (3–7 days) earlier in 4 (BioPlex) and 3 (ARCHITECT) of 6 seroconversion panels. ARCHITECT demonstrated the highest specificity (99.90–100%) compared to BioPlex (99.80%) and Centaur (99.42%). Conclusions The overall performance of ARCHITECT and BioPlex was superior to Centaur, especially for detection of acute HIV infection.
AB - Background HIV Ag/Ab combination assays are recommended by CDC for routine screening and several HIV Ag/Ab combination tests are now FDA-approved. Maintaining high specificity and consistent sensitivity across diverse HIV strains is critical for these assays to accurately detect HIV infection and expedite delivery of patient results. Objectives To evaluate performance of three FDA-approved HIV tests: ARCHITECT HIV Combo (Abbott), ADVIA Centaur HIV Combo (Siemens) and BioPlex HIV Ag-Ab (Bio-Rad). Study design Sensitivity and specificity were evaluated using an extensive panel of 28 HIV infected human specimens and 17 cultured virus isolates representing multiple genotypes, 6 seroconversion panels, 4 human samples with acute infection, WHO p24 standard and 4020 clinical specimens. Results The p24 limit of detection (LOD) for the WHO standard was 0.19 IU/ml, 0.70 IU/ml, and 1.77 IU/ml in BioPlex, ARCHITECT, and Centaur respectively. The distribution of LODs across 15 HIV-1 isolates was substantially narrower in ARCHITECT (5–33 pg/ml) than in BioPlex (11–198 pg/ml) and Centaur (6–384 pg/ml). All assays detected antibodies to the majority of HIV-1 and HIV-2 variants. However, reduced sensitivity was observed for Centaur in detection of antibodies to HIV-1 group M (CRF02_AG), O and N variants. BioPlex and ARCHITECT showed better seroconversion sensitivity than Centaur, detecting one bleed (3–7 days) earlier in 4 (BioPlex) and 3 (ARCHITECT) of 6 seroconversion panels. ARCHITECT demonstrated the highest specificity (99.90–100%) compared to BioPlex (99.80%) and Centaur (99.42%). Conclusions The overall performance of ARCHITECT and BioPlex was superior to Centaur, especially for detection of acute HIV infection.
KW - Acute HIV infection
KW - Clinical specificity
KW - Genetic diversity
KW - HIV antigen and antibody combination test
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U2 - 10.1016/j.jcv.2017.05.005
DO - 10.1016/j.jcv.2017.05.005
M3 - Article
C2 - 28535437
AN - SCOPUS:85019373193
SN - 1386-6532
VL - 92
SP - 62
EP - 68
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
ER -