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Journal of Clinical Microbiology, August 2000, p. 2837-2845, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Performance Characteristics of the QUANTIPLEX HIV-1 RNA 3.0 Assay for Detection and Quantitation of Human Immunodeficiency Virus Type 1 RNA in Plasma

Alejo Erice,1,dagger ,* Donald Brambilla,2,3 James Bremer,3,4 J. Brooks Jackson,5,dagger Robert Kokka,6 Belinda Yen-Lieberman,7 and Robert W. Coombs8,dagger

Department of Laboratory Medicine & Pathology and Department of Medicine, Division of Infectious Diseases, University of Minnesota, Minneapolis, Minnesota1; New England Research Institutes, Watertown, Massachusetts2; Rush Presbyterian-St. Luke's Medical Center, Chicago, Illinois4; Department of Pathology, Johns Hopkins University, Baltimore, Maryland5; Bayer Nucleic Acid Diagnostics, Emeryville, California6; Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio7; Department of Laboratory Medicine, University of Washington, Seattle, Washington8; and the Virology Quality Assurance Laboratory Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland3

Received 27 March 2000/Accepted 10 May 2000

The QUANTIPLEX HIV-1 RNA assay, version 3.0 (a branched DNA, version 3.0, assay [bDNA 3.0 assay]), was evaluated by analyzing spiked and clinical plasma samples and was compared with the AMPLICOR HIV-1 MONITOR Ultrasensitive (ultrasensitive reverse transcription-PCR [US-RT-PCR]) method. A panel of spiked plasma samples that contained 0 to 750,000 copies of human immunodeficiency virus type 1 (HIV-1) RNA per ml was tested four times in each of four laboratories (1,344 assays). Negative results (<50 copies/ml) were obtained in 30 of 32 (94%) assays with seronegative samples, 66 of 128 (52%) assays with HIV-1 RNA at 50 copies/ml, and 5 of 128 (4%) assays with HIV-1 RNA at 100 copies/ml. The assay was linear from 100 to 500,000 copies/ml. The within-run standard deviation (SD) of the log10 estimated HIV-1 RNA concentration was 0.08 at 1,000 to 500,000 copies/ml, increased below 1,000 copies/ml, and was 0.17 at 100 copies/ml. Between-run reproducibility at 100 to 500 copies/ml was <0.10 log10 in most comparisons. Interlaboratory differences across runs were <= 0.10 log10 at all concentrations examined. A subset of the panel (25 to 500 copies/ml) was also analyzed by the US-RT-PCR assay. The within-run SD varied inversely with the log10 HIV-1 RNA concentration but was higher than the SD for the bDNA 3.0 assay at all concentrations. Log-log regression analysis indicated that the two methods produced very similar estimates at 100 to 500 copies/ml. In parallel testing of clinical specimens with low HIV-1 RNA levels, 80 plasma samples with <50 copies/ml by the US-RT-PCR assay had <50 copies/ml when they were retested by the bDNA 3.0 assay. In contrast, 11 of 78 (14%) plasma samples with <50 copies/ml by the bDNA 3.0 assay had >= 50 copies/ml when they were retested by the US-RT-PCR assay (median, 86 copies/ml; range, 50 to 217 copies/ml). Estimation of bDNA 3.0 values of <50 copies/ml by extending the standard curve of the assay showed that these samples with discrepant results had higher HIV-1 RNA levels than the samples with concordant results (median, 34 versus 17 copies/ml; P = 0.0051 by the Wilcoxon two-sample test). The excellent reproducibility, broad linear range, and good sensitivity of the bDNA 3.0 assay make it a very attractive method for quantitation of HIV-1 RNA levels in plasma.

* Corresponding author. Mailing address: University of Minnesota, Box 437 Mayo, 420 Delaware St. SE, Minneapolis, MN 55455. Phone: (612) 626-0920. Fax: (612) 625-5468. E-mail: erice001{at}tc.umn.edu.

dagger Members of the Virology Subcommittee of the Adult AIDS Clinical Trials Group HIV Disease Research Agenda Committee.

Journal of Clinical Microbiology, August 2000, p. 2837-2845, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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