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Journal of Clinical Microbiology, July 2002, p. 2408-2419, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2408-2419.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Highly Sensitive Multiplex Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA

C. Giachetti,* J. M. Linnen, D. P. Kolk, J. Dockter, K. Gillotte-Taylor, M. Park, M. Ho-Sing-Loy, M. K. McCormick, L. T. Mimms, and S. H. McDonough

Research and Development, Gen-Probe Incorporated, San Diego, California 92121

Received 25 May 2001/ Returned for modification 12 November 2001/ Accepted 13 April 2002

Various nucleic acid assays have been developed and implemented for diagnostics and therapeutic monitoring of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) infections. The high-throughput, semiautomated assays described here were developed to provide a method suitable for screening plasma specimens for the presence of HIV-1 and HCV RNAs. Three assays were developed: a multiplex HIV-1/HCV assay for simultaneous detection of HIV-1 and HCV, and discriminatory assays for specific detection of HIV-1 and HCV. The assay systems utilize three proprietary technologies: (i) target capture-based sample preparation, (ii) transcription-mediated amplification (TMA), and (iii) hybridization protection assay (HPA). An internal control is incorporated into each reaction to control for every step of the assay and identify random false-negative reactions. The assays demonstrated a sensitivity of at least 100 copies/ml for each target, and they detected with similar sensitivity all major variants of HCV and HIV-1, including HIV-1 group O strains. Assay sensitivity for one virus was not affected by the presence of the other. The specificity of these TMA-driven assays was >=99.5% in both normal donor specimens and plasma containing potentially interfering substances or other blood-borne pathogens. Statistical receiver operating characteristic plots of 1 - specificity versus sensitivity data determined very wide analyte cutoff values for each assay at the point at which the assay specificity and sensitivity were both >=99.5%. The sensitivity, specificity, and throughput capability predict that these assays will be valuable for large-volume plasma screening, either in a blood bank setting or in other diagnostic applications.

* Corresponding author. Mailing address: Research and Development, Gen-Probe Incorporated, 10210 Genetic Center Drive, San Diego, CA 92121. Phone: (858) 410-8827. Fax: (858) 410-8871. E-mail: cristig{at}gen-probe.com.

Journal of Clinical Microbiology, July 2002, p. 2408-2419, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2408-2419.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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