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Sensitivity of high‐risk HPV H ybrid C apture II (hrHPV HC2) test using S ure P ath TM specimens in the prediction of cervical high‐grade squamous lesions
Author(s) -
Zhou Fang,
Pulinthanathu Rajiv,
Elgert Paul,
Cangiarella Joan,
Simsir Aylin
Publication year - 2015
Publication title -
diagnostic cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.417
H-Index - 65
eISSN - 1097-0339
pISSN - 8755-1039
DOI - 10.1002/dc.23243
Subject(s) - medicine , cytology , cervical intraepithelial neoplasia , gold standard (test) , biopsy , cervical screening , gynecology , cohort , cervical cancer , cancer , pathology
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. Diagn. Cytopathol. 2015;43:381–387. © 2014 Wiley Periodicals, Inc.