Cervista Human Papillomavirus Research Articles

Patient Safety and the Next Generation of HPV DNA Tests

To the Editor The special commentary, “Patient Safety and the Next Generation of HPV DNA Tests,” by Kinney et al1 asserted that the analytic and clinical sensitivity of the US Food and Drug Administration (FDA) newly approved Cervista human papillomavirus (HPV) test (Hologic, Bedford, MA) is too high for the test kit to be used clinically because it generates 2 to 4 times more positive results than the other FDA-approved Hybrid Capture 2 (HC2) HPV DNA test (Qiagen, Gaithersburg, MD). The authors further stated “any new test must demonstrate acceptable clinical performance based on the standards of reliable clinical sensitivity and specificity set by the community of experts,” designating Drs Stoler, Castle, Solomon, and Schiffman as the experts in a reference.2 The first author of the Special Commentary, Dr Kinney, should have known that neither of the 2 FDA-approved HPV DNA tests has been validated according to the experts’ set standards of “accounting for the majority (>90%) of CIN3+ [cervical intraepithelial neoplasia, grade 3 or more].” As a consultant to Digene in 2002, he presented data to the FDA in support of approval of the HC2 HPV assay, and stated on public record “because invasive cancer is not an option for an endpoint, CIN2+ was used as the clinically relevant endpoint instead.”3 At this FDA premarketing approval open session advisory meeting, the HC2 assay was proposed “for use as a general population screening test in conjunction with the Papanicolaou (Pap) smear for women age 30 and older, as an aid to determining the absence of high-grade cervical disease or cancer.”3 How to use HPV test results to determine the presence of high-grade cervical disease or cancer was not on the agenda for discussion. Now, postmarketing surveys have shown that about 95% of the referrals to colposcopic …

Clinical Experience with the Cervista HPV HR Assay: Correlation of Cytology and HPV Status from 56,501 Specimens

Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. Herein is described our clinical experience using Cervista HPV HR, a testing platform recently approved by the US Food and Drug Administration for clinical use. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature.