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

Correspondence: Keith V Nance Department of Pathology, Rex Hospital, 4420 Lake Boone Trail, Raleigh, NC, USA Tel +1 919 784 3063 Fax +1 919 784 3362 Email [email protected] Dear Editor Recently 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.” 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 SurePathTM (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. In their response to my letter they noted that a 10% false negative rate for women with invasive cervical carcinoma tested by the HC2 method using US Food and Drug Administration (FDA)-approved collection media tested within one year of the cancer diagnosis is the norm and is consistent with previous estimates of achievable HPV test sensitivity. This is most likely due to a low HPV viral load in the negative samples. They also correctly pointed out that such data is available for only a limited number of cases tested using HC2 on SurePathTM samples. They then reiterated their call for a nationwide data collection effort to document the likelihood of false negative hrHPV test results for all HPV testing methods over the 5–10 year period preceding histopathologic cervical cancer diagnoses. In this communication I respond to their call. Our laboratory uses the FDA-approved HC2 hrHPV method on SurePathTM Pap media which does not have FDA-approval for hrHPV testing. This testing methodology is used based on the results of an in-house validation performed under Clinical Laboratory Improvement Amendments (CLIA) guidelines and has enjoyed excellent College of American Pathologists (CAP) hrHPV proficiency testing results. This retrospective study focuses on the sensitivity of this testing for invasive cervical squamous carcinoma in our low risk patient population. Our methodology included identifying all histologically confirmed cervical squamous carcinoma cases at our institution from 2002–2012. Prior Pap test and hrHPV test records were reviewed for each patient. The results include 48 cases of carcinoma. Thirty-one of the 48 (65%) had Pap tests and seven of 48 (15%) had hrHPV tests within 5 years of diagnosis. All seven hrHPV tests were performed by HC2 on SurePathTM samples. Dovepress