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J Clin Virol. 2017 Jul;92:62-68. doi: 10.1016/j.jcv.2017.05.005. Epub 2017 May 13.

Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens.

Author information

1
Infectious Disease Research, Abbott, Diagnostics, Abbott Park, IL, United States. Electronic address: xiaoxing.qiu@abbott.com.
2
Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, United States.
3
Department of Laboratory Medicine and Pathobiology, University of Toronto and University Health Network, Toronto, ON, Canada.
4
Infectious Disease Research, Abbott, Diagnostics, Abbott Park, IL, United States.

Abstract

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 0.19IU/ml, 0.70IU/ml, and 1.77IU/ml in BioPlex, ARCHITECT, and Centaur respectively. The distribution of LODs across 15 HIV-1 isolates was substantially narrower in ARCHITECT (5-33pg/ml) than in BioPlex (11-198pg/ml) and Centaur (6-384pg/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.

KEYWORDS:

Acute HIV infection; Clinical specificity; Genetic diversity; HIV antigen and antibody combination test

PMID:
28535437
DOI:
10.1016/j.jcv.2017.05.005
[Indexed for MEDLINE]
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