Evaluation of NucliSens EasyQ™ HIV-1 assay for quantification of HIV-1 subtypes prevalent in South-east Asia

Lam, H.Y.; Chen, J.H.K.; Wong, K.H.; Chan, K.; Li, P.; Lee, M.P.; Tsang, D.N.; Yuen, K.Y.; Yam, W.C.

doi:10.1016/j.jcv.2006.10.002

« Previous Next »Journal of Clinical Virology
Volume 38, Issue 1 , Pages 39-43, January 2007

Evaluation of NucliSens EasyQ™ HIV-1 assay for quantification of HIV-1 subtypes prevalent in South-east Asia

H.Y. Lam
- Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China
J.H.K. Chen
- Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China
K.H. Wong
- Integrated Treatment Centre, Special Preventive Programme, Centre of Health Protection, Department of Health, Hong Kong SAR, China
K. Chan
- Integrated Treatment Centre, Special Preventive Programme, Centre of Health Protection, Department of Health, Hong Kong SAR, China
P. Li
- Department of Medicine, The Queen Elizabeth Hospital, Hong Kong SAR, China
M.P. Lee
- Department of Medicine, The Queen Elizabeth Hospital, Hong Kong SAR, China
D.N. Tsang
- Department of Pathology, The Queen Elizabeth Hospital, Hong Kong SAR, China
K.Y. Yuen
- Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China
W.C. Yam
- Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China
- Corresponding author. Tel.: +852 28554892; fax: +852 28551241.

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.

Keywords: Viral load monitoring, HIV-1, NucliSens EasyQ™, COBAS Amplicor™, Subtype diversity