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

被引:35
作者
Erice, A
Brambilla, D
Bremer, J
Jackson, JB
Kokka, R
Yen-Lieberman, B
Coombs, RW
机构
[1] Univ Minnesota, Dept Lab Med & Pathol, Minneapolis, MN 55455 USA
[2] Univ Minnesota, Dept Med, Div Infect Dis, Minneapolis, MN 55455 USA
[3] New England Res Inst, Watertown, MA 02172 USA
[4] Rush Presbyterian St Lukes Med Ctr, Chicago, IL 60612 USA
[5] Johns Hopkins Univ, Dept Pathol, Baltimore, MD USA
[6] Bayer Nucle Acid Diagnost, Emeryville, CA USA
[7] Cleveland Clin, Dept Clin Pathol, Cleveland, OH USA
[8] Univ Washington, Dept Lab Med, Seattle, WA 98195 USA
[9] NIAID, Div Aids, Virol Qual Assurance Lab Program, Bethesda, MD 20892 USA
关键词
D O I
10.1128/JCM.38.8.2837-2845.2000
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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 log(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 <0.10 log(10) in most comparisons. Interlaboratory differences across runs were less than or equal to 0.10 log(10) 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 log(10) 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 greater than or equal to 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.
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收藏
页码:2837 / 2845
页数:9
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