Source:http://linkedlifedata.com/resource/pubmed/id/10921936
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
8
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| pubmed:dateCreated |
2000-9-20
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| pubmed:abstractText |
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 </=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 >/=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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| pubmed:grant | |
| pubmed:commentsCorrections |
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| pubmed:language |
eng
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| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical | |
| pubmed:status |
MEDLINE
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| pubmed:month |
Aug
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| pubmed:issn |
0095-1137
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| pubmed:author | |
| pubmed:issnType |
Print
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| pubmed:volume |
38
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| pubmed:owner |
NLM
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| pubmed:authorsComplete |
Y
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| pubmed:pagination |
2837-45
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| pubmed:dateRevised |
2009-11-18
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| pubmed:meshHeading |
pubmed-meshheading:10921936-DNA Probes,
pubmed-meshheading:10921936-Evaluation Studies as Topic,
pubmed-meshheading:10921936-HIV Infections,
pubmed-meshheading:10921936-HIV-1,
pubmed-meshheading:10921936-Humans,
pubmed-meshheading:10921936-Laboratories,
pubmed-meshheading:10921936-Nucleic Acid Hybridization,
pubmed-meshheading:10921936-RNA, Viral,
pubmed-meshheading:10921936-Reagent Kits, Diagnostic,
pubmed-meshheading:10921936-Reproducibility of Results,
pubmed-meshheading:10921936-Reverse Transcriptase Polymerase Chain Reaction,
pubmed-meshheading:10921936-Sensitivity and Specificity,
pubmed-meshheading:10921936-Viremia
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| pubmed:year |
2000
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| pubmed:articleTitle |
Performance characteristics of the QUANTIPLEX HIV-1 RNA 3.0 assay for detection and quantitation of human immunodeficiency virus type 1 RNA in plasma.
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| pubmed:affiliation |
Department of Laboratory Medicine & Pathology Division of Infectious Diseases, University of Minnesota, Minneapolis, Minnesota 55455, USA. erice001@tc.umn.edu
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| pubmed:publicationType |
Journal Article,
Comparative Study,
Research Support, U.S. Gov't, P.H.S.,
Research Support, Non-U.S. Gov't
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