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Journal of Clinical Microbiology, January 2003, p. 164-173, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.164-173.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of the Performance Characteristics of the NucliSens HIV-1 QT Assay Used for Quantitation of Human Immunodeficiency Virus Type 1 RNA

Christine C. Ginocchio,1,2* Marti Kemper,3 Kathleen A. Stellrecht,4 and Donald J. Witt5

Department of Laboratory Medicine, North Shore University Hospital-New York University School of Medicine, Manhasset,1 North Shore-Long Island Jewish Health System Laboratories, Lake Success,2 Department of Pathology and Laboratory Medicine, Albany Medical Center, Albany, New York,4 Center for Blood Research, Sacramento Medical Foundation, Sacramento, California,3 bioMérieux Inc., Durham, North Carolina5

Received 13 May 2002/ Returned for modification 11 August 2002/ Accepted 5 October 2002

The analytical performance of the NucliSens HIV-1 QT assay, a highly sensitive test based on nucleic acid sequence-based amplification technology, was evaluated in a multicenter trial. Assay specificity was evaluated with 502 plasma (EDTA) specimens from human immunodeficiency virus type 1 (HIV-1)-seronegative volunteer donors. No HIV-1 RNA was reported in any of the donor specimens. Analytical sensitivity and reproducibility were estimated with panels prepared from a high-titer well-characterized HIV-1 RNA stock (5.84 x 108 RNA copies/ml). The assay's dynamic range was linear from 106 to 101 HIV-1 RNA copies, with a lower detectable limit of 25 copies/ml and a 95% detection rate of 176 copies/ml. Sensitivity of the assay to detect HIV-1 RNA in clinical specimens from patients (n = 101) and in commercially available or prepared panels (n = 24) was compared with NASBA HIV-1 RNA QT (an earlier version of NucliSens HIV-1 QT) and with the Food and Drug Administration-approved standard and ultrasensitive AMPLICOR HIV-1 MONITOR, version 1.0, assays. Detection of HIV-1 RNA was reproducible over a 5-log range (mean standard deviation = 0.15 log). The NucliSens and the standard AMPLICOR assays were equivalent in detection of HIV-1 RNA (concentration, 103 to 105 copies/ml) in 57 clinical specimens. The NucliSens assay was more sensitive in detecting HIV-1 RNA at lower concentrations (<=102 copies/ml) (44 of 44) than either the standard AMPLICOR test (12 of 19) or the NASBA assay (10 of 25). A 25% increase in HIV-1 RNA detection frequency with panels was observed with the NucliSens assay (23 of 24) compared with the standard AMPLICOR test (17 of 24). The new assay was highly specific and demonstrated good sensitivity with a broad linear dynamic range.

* Corresponding author. Present address: North Shore-Long Island Jewish Health System Laboratories, 10 Nevada Dr., Lake Success, NY 11042. Phone: (516) 719-1079. Fax: (516) 719-1254. E-mail: cginocch{at}nshs.edu.

Journal of Clinical Microbiology, January 2003, p. 164-173, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.164-173.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Holguin, A., Lopez, M., Molinero, M., Soriano, V. (2008). Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants. J. Clin. Microbiol. 46: 2918-2923 [Abstract] [Full Text]  


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