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PMID: 11060065 Published · ppublish English Comparative Study Evaluation Study Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Multicenter comparison of Roche COBAS AMPLICOR MONITOR version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex version 3.0 for quantification of human immunodeficiency virus type 1 RNA in plasma.

Journal of clinical microbiology ·Vol. 38 ·No. 11 ·2000-11-00 ·Pages 4034-41

Murphy DG, Côté L, Fauvel M, René P, Vincelette J

Abstract

The performance and characteristics of Roche COBAS AMPLICOR HIV-1 MONITOR version 1.5 (CA MONITOR 1.5) UltraSensitive (usCA MONITOR 1. 5) and Standard (stCA MONITOR 1.5) procedures, Organon Teknika NucliSens HIV-1 RNA QT with Extractor (NucliSens), and Bayer Quantiplex HIV RNA version 3.0 (bDNA 3.0) were compared in a multicenter trial. Samples used in this study included 460 plasma specimens from human immunodeficiency virus (HIV) type 1 (HIV-1)-infected persons, 100 plasma specimens from HIV antibody (anti-HIV)-negative persons, and culture supernatants of HIV-1 subtype A to E isolates diluted in anti-HIV-negative plasma. Overall, bDNA 3.0 showed the least variation in RNA measures upon repeat testing. For the Roche assays, usCA MONITOR 1.5 displayed less variation in RNA measures than stCA MONITOR 1.5. NucliSens, at an input volume of 2 ml, showed the best sensitivity. Deming regression analysis indicated that the results of all three assays were significantly correlated (P < 0.0001). However, the mean difference in values between CA MONITOR 1.5 and bDNA 3.0 (0.274 log(10) RNA copies/ml; 95% confidence interval, 0.192 to 0.356) was significantly different from 0, indicating that CA MONITOR 1.5 values were regularly higher than bDNA 3.0 values. Upon testing of 100 anti-HIV-negative plasma specimens, usCA MONITOR 1.5 and NucliSens displayed 100% specificity, while bDNA 3.0 showed 98% specificity. NucliSens quantified 2 of 10 non-subtype B viral isolates at 1 log(10) lower than both CA MONITOR 1.5 and bDNA 3.0. For NucliSens, testing of specimens with greater than 1,000 RNA copies/ml at input volumes of 0.1, 0.2, and 2.0 ml did not affect the quality of results. Additional factors differing between assays included specimen throughput and volume requirements, limit of detection, ease of execution, instrument work space, and costs of disposal. These characteristics, along with assay performance, should be considered when one is selecting a viral load assay.

MeSH Terms
Branched DNA Signal Amplification Assay/economics Costs and Cost Analysis DNA, Viral/analysis HIV Infections/virology HIV-1/isolation & purification,physiology Humans Nucleic Acid Amplification Techniques/economics RNA, Viral/blood Reagent Kits, Diagnostic/economics Reproducibility of Results Reverse Transcriptase Polymerase Chain Reaction/economics Sensitivity and Specificity Viral Load
Chemicals
DNA, Viral RNA, Viral Reagent Kits, Diagnostic
Authors & Affiliations
5 authors, click to expand affiliations / ORCID
Murphy D G
Laboratoire de Santé Publique du Québec, Sainte-Anne-de-Bellevue, Montréal, Canada.
Côté L
Fauvel M
René P
Vincelette J
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Article Info
Journal
Journal of clinical microbiology
Abbr.
J Clin Microbiol
ISSN
0095-1137
DOI
10.1128/JCM.38.11.4034-4041.2000
Published
2000-11-00
Pages
4034-41
Language
English
Region
United States
NLM ID
7505564
PMCID
PMC87538
Subset
IM
Corrections
ErratumIn
-
External Links
PubMed source DOI: 10.1128/JCM.38.11.4034-4041.2000 PMC Full Text View journal details
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