Analytic and clinical performance of cobas HPV testing in anal specimens from HIV-positive men who have sex with men

Nicolas Wentzensen, Stephen Follansbee, Sylvia Borgonovo, Diane Tokugawa, Vikrant V. Sahasrabuddhe, Jie Chen, Thomas S. Lorey, Julia C. Gage, Barbara Fetterman, Sean Boyle, Mark Sadorra, Scott Dahai Tang, Teresa M. Darragh, Philip E. Castle

Research output: Contribution to journalArticle

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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 (Ptrend < 0.001), HPV18 (Ptrend = 0.07), and other carcinogenic types (Ptrend < 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.

Original languageEnglish (US)
Pages (from-to)2892-2897
Number of pages6
JournalJournal of Clinical Microbiology
Volume52
Issue number8
DOIs
StatePublished - 2014
Externally publishedYes

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HIV
Cell Biology
Anus Neoplasms
Sensitivity and Specificity
Papillomavirus Infections
Neoplasms
Incidence

ASJC Scopus subject areas

  • Microbiology (medical)

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Analytic and clinical performance of cobas HPV testing in anal specimens from HIV-positive men who have sex with men. / Wentzensen, Nicolas; Follansbee, Stephen; Borgonovo, Sylvia; Tokugawa, Diane; Sahasrabuddhe, Vikrant V.; Chen, Jie; Lorey, Thomas S.; Gage, Julia C.; Fetterman, Barbara; Boyle, Sean; Sadorra, Mark; Tang, Scott Dahai; Darragh, Teresa M.; Castle, Philip E.

In: Journal of Clinical Microbiology, Vol. 52, No. 8, 2014, p. 2892-2897.

Research output: Contribution to journalArticle

Wentzensen, N, Follansbee, S, Borgonovo, S, Tokugawa, D, Sahasrabuddhe, VV, Chen, J, Lorey, TS, Gage, JC, Fetterman, B, Boyle, S, Sadorra, M, Tang, SD, Darragh, TM & Castle, PE 2014, 'Analytic and clinical performance of cobas HPV testing in anal specimens from HIV-positive men who have sex with men', Journal of Clinical Microbiology, vol. 52, no. 8, pp. 2892-2897. https://doi.org/10.1128/JCM.03517-13
Wentzensen, Nicolas ; Follansbee, Stephen ; Borgonovo, Sylvia ; Tokugawa, Diane ; Sahasrabuddhe, Vikrant V. ; Chen, Jie ; Lorey, Thomas S. ; Gage, Julia C. ; Fetterman, Barbara ; Boyle, Sean ; Sadorra, Mark ; Tang, Scott Dahai ; Darragh, Teresa M. ; Castle, Philip E. / Analytic and clinical performance of cobas HPV testing in anal specimens from HIV-positive men who have sex with men. In: Journal of Clinical Microbiology. 2014 ; Vol. 52, No. 8. pp. 2892-2897.
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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 (Ptrend < 0.001), HPV18 (Ptrend = 0.07), and other carcinogenic types (Ptrend < 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.",
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AU - Tang, Scott Dahai

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AU - Castle, Philip E.

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