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Journal of Clinical Microbiology, March 1999, p. 812-814, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Reproducibility and Performance of the Second-Generation Branched-DNA Assay in Routine Quantification of Human Immunodeficiency Virus Type 1 RNA in Plasma

Donald G. Murphy,1,2,* Patrick Gonin,1 and Micheline Fauvel1

Laboratoire de Santé Publique du Québec, Sainte-Anne-de-Bellevue,1 and Département de Microbiologie et Immunologie, Université de Montréal, Montréal,2 Québec, Canada

Received 16 July 1998/Returned for modification 28 September 1998/Accepted 18 November 1998

We examined the reproducibility of a second-generation branched-DNA (bDNA) assay (Quantiplex HIV RNA 2.0) for quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma by retesting 325 specimens on separate runs and on different lots. The performance of the bDNA test was also assessed by data analysis obtained during routine testing of 15,365 specimens. Upon retesting, 96 and 86% of specimens displaying RNA levels above 5,000 and between 500 and 5,000 copies/ml, respectively, showed less than a 0.3 log10 (twofold) difference with their initial values. Assay variability was found to increase as viral load decreased. Overall, the bDNA version 2.0 assay was found to be a reproducible and efficient test for routine quantification of HIV-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.

Journal of Clinical Microbiology, March 1999, p. 812-814, Vol. 37, No. 3
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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