title: Enhanced detection and typing of human papillomavirus (HPV) DNA in anogenital samples with PGMY primers and the Linear array HPV genotyping test.
abstract: 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.
authors.affiliation: Laboratoire de Virologie Moléculaire du centre de Recherche, Département de Microbiologie et Infectiologie, Hôpital Notre-Dame du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada. francois.coutlee@ssss.gouv.qc.ca
authors.forename: François
authors.initials: F
authors.lastname: Coutlée
authors.forename: Danielle
authors.initials: D
authors.lastname: Rouleau
authors.forename: Patrick
authors.initials: P
authors.lastname: Petignat
authors.forename: Georges
authors.initials: G
authors.lastname: Ghattas
authors.forename: Janet R
authors.initials: JR
authors.lastname: Kornegay
authors.forename: Peter
authors.initials: P
authors.lastname: Schlag
authors.forename: Sean
authors.initials: S
authors.lastname: Boyle
authors.forename: Catherine
authors.initials: C
authors.lastname: Hankins
authors.forename: Sylvie
authors.initials: S
authors.lastname: Vézina
authors.forename: Pierre
authors.initials: P
authors.lastname: Coté
authors.forename: John
authors.initials: J
authors.lastname: Macleod
authors.forename: Hélène
authors.initials: H
authors.lastname: Voyer
authors.forename: Pierre
authors.initials: P
authors.lastname: Forest
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
authors.forename: Eduardo
authors.initials: E
authors.lastname: Franco
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000821:virology*; D002584:Cervix Uteri / Q000821:virology*; D002648:Child; D017931:DNA Primers; D004279:DNA, Viral / Q000032:analysis* / Q000302:isolation & purification; D005260:Female; D005831:Genital Diseases, Female / Q000821:virology; D005832:Genital Diseases, Male / Q000821:virology; D005838:Genotype; D006679:HIV Seropositivity / Q000150:complications; D006367:HeLa Cells; D006801:Humans; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods; D013048:Specimen Handling / Q000379:methods; D014621:Vagina / Q000821:virology*
chemical_list: D017931:DNA Primers; D004279:DNA, Viral