Sensitivity of high-risk HPV Hybrid Capture II (hrHPV HC2) test using SurePath(TM) specimens in the prediction of cervical high-grade squamous lesions

Abstract

Introduction: High-risk HPV (hrHPV) testing is now considered standard of care in the detection and management of cervical high-grade squamous intraepithelial lesions (HSIL/CIN 2-3) and their precursors. Recently, there has been concern in the scientific literature and lay media about the lack of data regarding the false-negative rate (FNR) of HPV testing on SurePath(TM) cytology specimens. This is a critical issue, since guidelines on the management of Pap test abnormalities rely heavily on HPV status. We undertook this study to determine whether HPV testing on SurePath(TM) specimens is less sensitive compared to reports in the literature for ThinPrep®.

Methods: We identified women with new diagnoses of CIN 2, CIN 3, and squamous cell carcinoma (SCC) on biopsy or excision in 2009-2013. For each patient, we recorded all SurePath(TM) cytology and hrHPV HC2 (high-risk HPV Hybrid Capture 2) test results from within 5 years prior to histologic diagnosis. Using the histologic diagnosis as the gold standard, we calculated the sensitivities of cytology and hrHPV HC2 tests for the detection of CIN 2, 3, and SCC. Our findings are based only on women who underwent biopsy or excision after having an abnormal cytology and/or positive HPV result.

Results: In our cohort, the sensitivity of testing in the 5 years prior to histologic diagnosis of CIN 2, 3, and SCC (combined as a single group) is 98.4% for SurePath(TM) cytology, 95.3% for hrHPV HC2, and 100% if both tests are used together. No conclusion can be drawn regarding testing for SCC alone, because there was only one case of SCC.

Conclusion: Our results show that the false-negative rate of hrHPV HC2 testing on SurePath(TM) specimens for the detection of CIN 2 and CIN 3 is low and comparable to that of ThinPrep® specimens.

Keywords: Hybrid Capture II; SurePath; cervical intraepithelial neoplasia; false-negative rate; high-risk HPV; sensitivity.