title: Analytic and clinical performance of cobas HPV testing in anal specimens from HIV-positive men who have sex with men.
abstract: Anal human papillomavirus (HPV) infections are common, and the incidence of anal cancer is high in HIV-infected men who have sex with men (MSM). To evaluate the performance of HPV assays in anal samples, we compared the cobas HPV test (cobas) to the Roche Linear Array HPV genotyping assay (LA) and cytology in HIV-infected MSM. Cytology and cobas and LA HPV testing were conducted for 342 subjects. We calculated agreement between the HPV assays and the clinical performance of HPV testing and HPV genotyping alone and in combination with anal cytology. We observed high agreement between cobas and LA, with cobas more likely than LA to show positive results for HPV16, HPV18, and other carcinogenic types. Specimens testing positive in cobas but not in LA were more likely to be positive for other markers of HPV-related disease compared to those testing negative in both assays, suggesting that at least some of these were true positives for HPV. cobas and LA showed high sensitivities but low specificities for the detection of anal intraepithelial neoplasia grade 2/3 (AIN2/3) in this population (100% sensitivity and 26% specificity for cobas versus 98.4% sensitivity and 28.9% specificity for LA). A combination of anal cytology and HPV genotyping provided the highest accuracy for detecting anal precancer. A higher HPV load was associated with a higher risk of AIN2/3 with HPV16 (P(trend) < 0.001), HPV18 (P(trend) = 0.07), and other carcinogenic types (P(trend) < 0.001). We demonstrate that cobas can be used for HPV detection in anal cytology specimens. Additional tests are necessary to identify men at the highest risk of anal cancer among those infected with high-risk HPV.
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA wentzenn@mail.nih.gov.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
authors.affiliation: Kaiser Permanente Medical Center, San Francisco, California, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Follansbee
authors.affiliation: Kaiser Permanente Medical Center, San Francisco, California, USA.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Borgonovo
authors.affiliation: Kaiser Permanente TPMG Regional Laboratory, Berkeley, California, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Tokugawa
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Vikrant V
authors.initials: VV
authors.lastname: Sahasrabuddhe
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Jie
authors.initials: J
authors.lastname: Chen
authors.affiliation: Kaiser Permanente TPMG Regional Laboratory, Berkeley, California, USA.
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Lorey
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Julia C
authors.initials: JC
authors.lastname: Gage
authors.affiliation: Kaiser Permanente TPMG Regional Laboratory, Berkeley, California, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Fetterman
authors.affiliation: Roche Molecular Systems, Pleasanton, California, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Boyle
authors.affiliation: Roche Molecular Systems, Pleasanton, California, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Sadorra
authors.affiliation: Roche Molecular Systems, Pleasanton, California, USA.
authors.forename: Scott Dahai
authors.initials: SD
authors.lastname: Tang
authors.affiliation: University of California, San Francisco, California, USA.
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Darragh
authors.affiliation: Global Cancer Initiative, Chestertown, Maryland, USA.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000293:Adolescent; D000328:Adult; D001004:Anus Diseases / Q000175:diagnosis* / Q000821:virology; D003584:Cytological Techniques / Q000379:methods; D060005:Genotyping Techniques / Q000379:methods*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D055815:Young Adult