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Journal of Clinical Microbiology, November 2000, p. 4034-4041, Vol. 38, No. 11
Laboratoire de Santé Publique du Québec,
Sainte-Anne-de-Bellevue,1 Département
de Microbiologie et Immunologie, Université de
Montréal,2 Centre Universitaire de
Santé McGill, Hôpital Royal Victoria,4 and
Centre Hospitalier de l'Université de Montréal, Hôpital
Saint-Luc,5 Montréal, and Centre
Hospitalier de l'Université Laval du Centre Hospitalier
Universitaire de Québec, Sainte-Foy,3
Québec, Canada
Received 8 June 2000/Returned for modification 1 August
2000/Accepted 23 August 2000
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 log10 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 log10 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.
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
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
*
Corresponding author. Mailing address: Laboratoire de
Santé Publique du Québec, 20045 Chemin Sainte-Marie,
Sainte-Anne-de-Bellevue, Québec, Canada H9X 3R5. Phone: (514)
457-2070. Fax: (514) 457-6346. E-mail: dmurphy{at}lspq.org.
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