Referral population studies underestimate differences between human papillomavirus assays in primary cervical screening

Abstract

Objective: We studied how representative cytologically abnormal women ("referral populations") are with respect to uncovering differences between human papillomavirus (HPV) assays in the primary screening where most women are cytologically normal.Methods: A total of 4997 women were tested with SurePathâ cytology, and Hybrid Capture 2 (HC2), cobas, CLART and APTIMA HPV assays. Women with positive test results were offered a follow-up. For all detected HPV infections and HPV-positive high-grade cervical intraepithelial neoplasia (≥CIN2), we studied the distributions of assay-specific signal strengths in the baseline samples as documented by the assays' automatically generated reports. We calculated the likelihood of test result discordance as the proportion of HPV-positive samples that were not confirmed by all four assays. Conclusions: These data suggest that referral population studies, by not including sufficient numbers of cytology normal women, underestimate the differences between HPV assays that would become apparent in primary screening.

Not all HPV nucleic acid tests are equal: only those calibrated to detect high grade lesions matter for cervical screening: Response to ‘Concordant testing results between various human papillomavirus assays in primary cervical cancer screening: systematic review’ by de Thurah, Bonde, Uyen, Lam and Rebolj. Published 27 May, 2017

“…Although we have repeatedly shown that inter-assay concordance is indeed less of a problem in women who would benefit from treatment of histologically confirmed lesions (cervical intraepithelial neoplasia of stage 2 or more; CIN2) [6e8], we also reported that assays show more discordant findings when these lesions are cytologically normal [8]. In plain terms, this occasional lack of concordance is the difference between detecting or missing a lesion that should be treated.…”

Cervical Cancer Screening Programs in Europe: The Transition Towards HPV Vaccination and Population-Based HPV Testing

“…Moreover, cotesting is also being performed in a pilot population-based program that is still ongoing in Malta [115]. Other countries, such as Denmark, which performs HPV testing for women in the age range of 60–64 [169,170] and Belgium [138], are still evaluating HPV primary screening for implementation in their national programs.…”

Human Papillomavirus Testing in the Last Cervical Screening Round at Age 60–64 Years

“… 13 The Patobank can be considered satisfactorily complete for cervical cytology since 2005 and for cervical histology since 2009. 14 Colposcopies are not registered in the Patobank. Because the national guidelines recommended taking blind biopsies if no lesion could be visualized colposcopically, a record of a biopsy was used as an indicator that a colposcopy took place.…”