Test Performance Comparison of Inform HPV and Hybrid Capture 2 High-Risk HPV DNA Tests Using the SurePath Liquid-Based Pap Test as the Collection Method

Abstract

No US Food and Drug Administration-approved method is available to test for human papillomavirus (HPV) DNA in the SurePath liquid-based Papanicolaou (Pap) test (TriPath Care Technologies, Burlington, NC). We compared the performance characteristics of Inform HPV (Ventana Medical Systems, Tucson, AZ) and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) using SurePath for collection. The study included samples from 102 women, aged 18 to 60 years, who underwent a SurePath Pap test immediately before colposcopy and cervical biopsy. Each SurePath specimen was processed additionally for Inform HPV and HC2. Performance characteristics were determined by using the cervical biopsy as the "gold standard." The SurePath, Inform HPV, and HC2 correctly identified high-grade squamous intraepithelial lesions (HSILs) in 15 (94%) of 16, 6 (38%) of 16, and 14 (93%) of 15 cases, respectively. When only SurePath samples with a diagnosis of atypical glandular and/or squamous cells were examined, Inform HPV and HC2 correctly identified HSIL in 19 (43%) of 44 and 45 (100%) of 45 cases, respectively. When SurePath is used for collection, Inform HPV lacks sufficient sensitivity to detect HSIL reliably.

A Human Papillomavirus Testing System in Women with Abnormal Pap Results

“…The NPV was also lower with INFORM HPV (89%) than with HC2 (100%). 10 In our study of 51 women with ASCUS, the sensitivity of the INFORM HPV for predicting CIN 2/3 was 60% (3 of 5), with an NPV of 94.4%. These studies demonstrated lack of sufficient sensitivity and NPV for detecting CIN 2/3 using the INFORM HPV in SurePath specimens.…”

Use of p63 for distinction of glandular versus squamous lesions in cervicovaginal specimens

“…The distinction between primary glandular pathology and HSIL that involves endocervical glands can be a diagnostic problem 12. In these specimens, groups of abnormal cells tend to round up during processing of fluid material, and they may be mistaken for cells of glandular origin.…”

Sensitivity of high‐risk HPVHybrid Capture II (hrHPV HC2) test using SurePathTM specimens in the prediction of cervical high‐grade squamous lesions

“…13 Our results are similar to others' reports of hrHPV HC2 testing on SurePath TM specimens. 11,12,[23][24][25] In published reports of hrHPV HC2 testing using ThinPrepV R specimens, the sensitivity of abnormal cytology ranges from 50% to 100% for predicting CIN 2 and above. 22 Storage duration and temperature are not reported and such a low sensitivity has not been replicated in other studies.…”