Evaluation of NucliSens EasyQ™ HIV-1 assay for quantification of HIV-1 subtypes prevalent in South-east Asia
Received 24 June 2006; received in revised form 6 October 2006; accepted 6 October 2006. published online 17 November 2006.
Abstract
Background
Monitoring anti-retroviral therapy requires that viral load assays for human immunodeficiency virus type 1 (HIV-1) be applicable to diverse HIV-1 subtypes.
Objectives
To evaluate NucliSens EasyQ™ HIV-1 assay for quantitation of common HIV-1 subtypes prevalent in South-east Asia.
Study design
One hundred and nineteen plasma samples collected in Hong Kong and Cambodia were used to compare the performance of NucliSens EasyQ™ HIV-1 and COBAS Amplicor™ HIV-1 Monitor version 1.5 assays. Viral RNA extracted from the NucliSens MiniMAG™ was also used for HIV-1 subtyping.
Results
Performance of NucliSens EasyQ™ correlated well with COBAS Amplicor™ (r=0.777, p<0.001) and the small mean difference (0.0462log10IU/mL) obtained in the Bland and Altman model indicated good agreement between two assays. The NucliSens EasyQ™ assay demonstrated a 95% sensitivity at 500IU/mL and 100% specificity. Reproducibility of this assay was within log102–4IU/mL and had a coefficient of variation between 2.3% and 10.4%. Among the 109 specimens included in the analysis, HIV-1 subtyping identified 64 CRF01_AE, 38 subtype B, 3 subtype C, 3 CRF07_BC and 1 subtype G viruses.
Conclusions
Performance of NucliSens EasyQ™ was comparable to COBAS Amplicor™ for HIV-1 viral load monitoring. RNA extracts from NucliSens MiniMAG™ could be used for HIV-1 viral load monitoring, subtyping and drug resistance mutations detection. Our findings highlight the versatility of both NucliSens EasyQ™ and COBAS Amplicor™ in monitoring prevalent subtypes and rare circulating recombinant forms (CRFs) in the South-east Asia region.
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