Performance characteristics of the QUANTIPLEX HIV-1 RNA 3.0 Assay for detection and quantitation of human immunodeficiency virus type 1 RNA in plasma

A. Erice, D. Brambilla, J. Bremer, J. B. Jackson, R. Kokka, B. Yen-Lieberman, R. W. Coombs

Research output: Contribution to journalArticle

Abstract

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 (10 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 10 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

Original languageEnglish (US)
Pages (from-to)2837-2845
Number of pages9
JournalJournal of Clinical Microbiology
Volume38
Issue number8
Publication statusPublished - 2000
Externally publishedYes

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ASJC Scopus subject areas

  • Microbiology (medical)
  • Microbiology

Cite this

Erice, A., Brambilla, D., Bremer, J., Jackson, J. B., Kokka, R., Yen-Lieberman, B., & Coombs, R. W. (2000). Performance characteristics of the QUANTIPLEX HIV-1 RNA 3.0 Assay for detection and quantitation of human immunodeficiency virus type 1 RNA in plasma. Journal of Clinical Microbiology, 38(8), 2837-2845.