Abstract
Periodic evaluation of the impact of viral diversity on diagnostic tests is critical to ensure current technologies are keeping pace with viral evolution. To determine whether HIV diversity impacts the ARCHITECT HIV Combo Ag/Ab (HIV Combo) or RealTime HIV-1 (RT) assays, a set of N = 199 HIV clinical specimens from Cameroon, Senegal, Saudi Arabia, and Thailand were sequenced and tested in both assays. The panel included historical groups N and P specimens and a newly identified group N specimen. These and specimens classified as H, U (unclassified)/URF (unique recombinant form), CRF (circulating recombinant form) 01, 02, 06, 09, 11, 13, 18, 22, 37, and 43 were detected by both the RT assay (1.75–6.84 log copies/ml) and the HIV Combo assay (3.26–1121.96 sample to cutoff ratios). Sequence alignment identified 3 or fewer mismatches to the RT assay oligos in 82.4% of samples. Altogether, these data demonstrate the HIV Combo and RT assays detect diverse strains of HIV in clinical specimens.
Highlights
Periodic evaluation of the impact of viral diversity on diagnostic tests is critical to ensure current technologies are keeping pace with viral evolution
The panel included historical groups N and P specimens and a newly identified group N specimen. These and specimens classified as H, U/ URF, circulating recombinant forms (CRFs) 01, 02, 06, 09, 11, 13, 18, 22, 37, and 43 were detected by both the RealTime HIV-1 (RT) assay (1.75–6.84 log copies/ml) and the HIV Combo assay (3.26–1121.96 sample to cutoff ratios)
The detection of diverse strains by the RealTime HIV-1 assay (RT; Abbott Molecular Diagnostics, Des Plaines, IL) and the HIV Combo Ag/Ab assay (HIV Combo; Abbott Diagnostics, Abbott Park, IL) reported in several recent publications largely relied on cultured virus isolates.[3,4,5,6,7,8,9]
Summary
Periodic evaluation of the impact of viral diversity on diagnostic tests is critical to ensure current technologies are keeping pace with viral evolution. To determine whether HIV diversity impacts the ARCHITECT HIV Combo Ag/ Ab (HIV Combo) or RealTime HIV-1 (RT) assays, a set of N = 199 HIV clinical specimens from Cameroon, Senegal, Saudi Arabia, and Thailand were sequenced and tested in both assays.
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