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Journal of Clinical Microbiology, June 2006, p. 1998-2006, Vol. 44, No. 6
0095-1137/06/$08.00+0 doi:10.1128/JCM.00104-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.
and
Eduardo Franco3
Laboratoire de Virologie Moléculaire du Centre de Recherche, Départements de Microbiologie et Infectiologie, Obstétrique-Gynécologie et Gastro-entérologie, Hôpital Notre-Dame du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada,1 Département de Microbiologie et Immunologie, Université de Montréal, Montréal, Québec, Canada,2 Division of Cancer Epidemiology and Department of Medicine, McGill University, Montreal, Quebec, Canada,3 Roche Molecular Systems, Alameda, California,4 Direction de la Santé Publique de Montréal-Centre, Institut National de Santé Publique du Québec, Montréal, Québec, Canada,5 Clinique Médicale l'Actuel, Montréal, Québec, Canada,6 Clinique Médicale du Quartier-Latin, Montréal, Québec, Canada,7 Division of Clinical Investigation and Human Physiology, Toronto General Research Institute, Toronto General Hospital, University of Toronto, Toronto, Canada8
Received 17 January 2006/ Returned for modification 7 March 2006/ Accepted 17 March 2006
The Roche PGMY primer-based research prototype line blot assay (PGMY-LB) is a convenient tool in epidemiological studies for the detection and typing of human papillomavirus (HPV) DNA. This assay has been optimized and is being commercialized as the Linear Array HPV genotyping test (LA-HPV). We assessed the agreement between LA-HPV and PGMY-LB for detection and typing of 37 HPV genotypes in 528 anogenital samples (236 anal, 146 physician-collected cervical, and 146 self-collected cervicovaginal swabs) obtained from human immunodeficiency virus-seropositive individuals (236 men and 146 women). HPV DNA was detected in 433 (82.0%) and 458 (86.7%) samples with PGMY-LB and LA-HPV (P = 0.047), respectively, for an excellent agreement of 93.8% (kappa = 0.76). Of the 17,094 HPV typing results, 16,562 (1,743 positive and 14,819 negative results) were concordant between tests (agreement = 96.9%; kappa = 0.76). The mean agreement between tests for each type was 96.4% ± 2.4% (95% confidence interval [CI], 95.6% to 97.2%; range, 86% to 100%), for an excellent mean kappa value of 0.85 ± 0.10 (95% CI, 0.82 to 0.87). However, detection rates for most HPV types were greater with LA-HPV. The mean number of types per sample detected by LA-HPV (4.2 ± 3.4; 95% CI, 3.9 to 4.5; median, 3.0) was greater than that for PGMY-LB (3.4 ± 3.0; 95% CI, 3.1 to 3.6; median, 2.0) (P < 0.001). The number of types detected in excess by LA-HPV in anal samples correlated with the number of types per sample (r = 0.49 ± 0.06; P = 0.001) but not with patient age (r = 0.03 ± 0.06; P = 0.57), CD4 cell counts (r = 0.06 ± 0.06; P = 0.13), or the grade of anal disease (r = 0.11 ± 0.06; P = 0.07). LA-HPV compared favorably with PGMY-LB but yielded higher detection rates for newer and well-known HPV types.
The Canadian Women's HIV Study Group includes the following members: in Halifax, Janet Conners, Rob Grimshaw, David Haase, Lynn Johnston, Wally Schlech, and Arlo Yuzicappi-Fayant; in Hamilton, Stephen Landis and Fiona Smaill; in London, Tom Austin, Ole Hammerberg, and Ted Ralph; in Montréal, François Coutlée, Julian Falutz, Alex Ferenczy, Catherine Hankins, Marina Klein, Louise Labrecque, Richard Lalonde, John Macleod, Grégoire Noël, Chantal Perron, Jean-Pierre Routy, and Emil Toma; in Ottawa, Claire Touchie and Garry Victor; in Québec, Louise Coté, Hélène Senay, and Sylvie Trottier; in Saskatoon, Kurt Williams; in Sherbrooke, Alain Piché; in Sudbury, Roger Sandre; in Toronto, Louise Binder, Donna Keystone, Anne Phillips, Anita Rachlis, Irving Salit, Cheryl Wagner, and Sharon Walmsley; and in Vancouver, Paula Braitstein, David Burdge, Marianne Harris, Deborah Money, and Julio Montaner.
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