Analytical performance of cervista HPV 16/18 in SurePath pap specimens.

Abstract

To evaluate the performance of Cervista HPV 16/18 in SurePath specimens, we compared the analytical sensitivity of Cervista HPV 16/18 with that of a previously validated PCR-based, commercially available HPV genotyping assay, EasyChip HPV Blot, in residual specimens collected after routine Pap tests at our cancer center. We retrospectively selected 79 consecutive Cervista HPV HR (high risk)-positive SurePath residual Pap specimens. The cytology results for these specimens comprised 42 negative, 22 ASC-US/ASC-H, 10 low-grade squamous intraepithelial lesions, and 5 high-grade squamous intraepithelial lesions. HPV 16/18 genotypes of the 79 specimens were analyzed by Cervista HPV 16/18 assay and EasyChip genotyping assay and compared with the patient's follow-up results. Of the 79 cases, 33 (42%) were positive for HPV16/18 by Cervista HPV 16/18 and 37 (47%) were positive by EasyChip. The overall agreement between the 2 assays, at 85% (67/79), was good (kappa = 0.698, 95% CI: 0.541-0.855). In the 65 patients with follow-up results, the sensitivity for predicting cervical intraepithelial neoplasia grade 2 or higher (CIN2+) was 77% for Cervista HPV 16/18 assay and 69% for EasyChip. The predictive values for CIN2+ in cases stratified by Pap results were highly consistent between the Cervista HPV16/18 and EasyChip assays; there was one false negative HPV16 result, in a specimen identified as NILM by EasyChip. Our findings support use of the Cervista HPV 16/18 assay for HPV16/18 genotyping in SurePath Pap specimens. However, further studies of larger cohorts with clinical follow-up data are required to verify the efficacy of Cervista HPV16/18 assay in SurePath Pap specimens.