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Journal of Clinical Microbiology, November 2000, p. 4034-4041, Vol. 38, No. 11
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

Donald G. Murphy,1,2,* Louise Côté,3 Micheline Fauvel,1 Pierre René,4 and Jean Vincelette2,5

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.

* 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.

Journal of Clinical Microbiology, November 2000, p. 4034-4041, Vol. 38, No. 11
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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