Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening

Keith V Nance Medical Directory of Cytology, Rex Hospital, Raleigh, and Department of Pathology, The University of North Carolina School of Medicine, Chapel Hill, NC, USAI read with interest the recently published article by Naryshkin and Austin entitled "Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening".1 The article is a single case report of squamous cell carcinoma of the cervix diagnosed in a patient who had negative Hybrid Capture 2 (Qiagen NV, Hilden, Germany) high-risk human papillomavirus testing from SurePath™ (Becton-Dickinson, Franklin Lakes, NJ) samples. The authors then discuss several valid points regarding the use of human papillomavirus testing and cervical cancer screening not approved by the US Food and Drug Administration (FDA). Their conclusion is that such testing should not be done using the SurePath collection medium.View the original paper by Naryshkin and Austin

Diagnostic sensitivity for invasive cervical carcinoma of high risk HPV tests performed on SurePath™ liquid-based pap specimens

Keith V NanceDepartment of Cytology, Rex Hospital, Raleigh, and Department of Pathology, The University of North Carolina School of Medicine, Chapel Hill, NC, USARecently I communicated with the Editor regarding Drs Naryshkin and Austins’ article entitled "Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical carcinoma screening."1,2 As noted previously, this article is based on a single case report of squamous cell carcinoma of the cervix diagnosed in a patient who had abnormal Pap results but had negative Hybrid Capture 2 (HC2)(Qiagen NV, Hilden, Germany) high risk human papillomavirus (hrHPV) testing from SurePath™ (Becton-Dickinson, Franklin Lakes, NJ, USA) samples. The authors concluded that such testing should not be done using this collection medium. Interestingly, they also mentioned a 10% false negative rate for similar testing performed on FDA-approved Preservcyt® media on three of 31 invasive cervical carcinoma patients at Dr Austin’s own laboratory.View original paper by Naryshkin and Austi