The hc2 human papillomavirus DNA test (HC2) is effective when screening women for cervical dysplasia, and it might be effective in the screening for anal dysplasia. Differences between the anal and the cervical canals could affect the test performance. This prospective study (n=292) measured the HC2 signal and in agreement with a histologic endpoint of high-grade dysplasia for anal specimens collected in various ways. Sensitivities were 91%, 85%, and 62% for specimens collected in a sample transport medium and a liquid-based cytology medium processed by Gyn or Non-Gyn protocol, respectively. HC2 sensitivity and specificity to predict high-grade anal dysplasia were similar for brush or swab specimen collections, but HC2 signal was 6 times higher with the brush. Specificity and sensitivity were similar whether the sample was collected first or after a cytology sample for brush or swab, but swab specimens at the second collection had an HC2 signal (mean) 48% lower than that of the first collection, and the swab cellularity was lower. The presence of maximum stool decreased the HC2 signal in anal swab specimens. Consensus polymerase chain reaction (PCR) confirmed that the 13 human papillomavirus probe types in HC2 were optimal for performance. HC2 could potentially be further investigated for use in screening anal dysplasia. A larger prospective study is indicated.
*Qiagen Gaithersburg Inc., Gaithersburg, MD
†Department of Surgery, Mount Sinai School of Medicine, New York, NY
Funding provided by Qiagen Gaithersburg Inc. S.E.G. has received funding from Qiagen Gaithersburg Inc., Gaithersburg, MD to carry out this clinical trial. He has also spoken on behalf of Qiagen Gaithersburg Inc. He has received grant support from Merck and Co. and the AIDS Malignancy Consortium. He has spoken on behalf of and served as a consultant for Merck and Co. B.L., S.R., H.S., G.C., and T.R. are employees of Qiagen Gaithersburg Inc.
The authors declare no conflict of interest.
Reprints: Brian Lowe, PhD, Qiagen Gaithersburg Inc., 1201 Clopper Road, Gaithersburg, MD 20878 (e-mail: firstname.lastname@example.org).