Human papillomavirus (HPV) and Pap cytology co-testing has been used in our institution for cervical cancer screening and post therapy surveillance. In our patient population, HPV testing performance by Hybrid Capture 2 (HC2, Qiagen, Valencia, CA) or Cervista HPV assay (Hologic Inc., Bedford, MA) is limited.
We retrospectively searched our institution’s database for women aged 30 years or older who underwent HPV/Pap cytology co-testing in our Cancer Prevention Center (CPC, for general screening population) or Gynecology Clinics (GYN, for cancer surveillance). HC2 HPV assay (2007-2010) or Cervista HPV assays (2011-2016) were used in both clinics. A total of 16,214 women from CPC (mean age, 55 years; 30-91 years) and 10,588 women from GYN clinics (mean age, 51 years; 30-96 years) were included in the study. HC2 and Cervista HPV assays were compared by HPV testing results stratified by Pap test results in both clinics. The differences were analyzed by Fisher’s exact test. A total of 175 follow-up biopsies from women who visited GYN clinic and had HSIL/carcinoma Pap results were reviewed. The sensitivity for predicting high-grade cervical intraepithelial lesion or carcinoma (CIN3+) was calculated for these women with HC2 or Cervista HPV assays.
In the CPC, HPV positive rates were significantly different between Cervista HPV (4.3%) and HC2 (3.4%, P=0.006) in women who had a Pap result of Negative for Intraepithelial Lesion or Malignancy (NILM). HPV positive rates were similar between HC2 (6.1%) and Cervista HPV assay (6.8%) in women with NILM Pap results in the GYN clinic (P=0.21). In the GYN clinics, HPV positive rates were moderately different between Cervista HPV (25.8%) and HC2 (20.7%) in women with Abnormal Squamous Cells of Undetermined Significance (ASC-US) Pap result (P=0.02). In women with High-grade Squamous Intraepithelial Lesion (HSIL) or carcinoma Pap results, HPV positivity was significantly lower by Cervista HPV (78.8%) than HC2 (92.4%) (P=0.008). However, no significant difference of the sensitivity of HPV to predict CIN3+ was observed between Cervista HPV (81.8%) and HC2 (89.2%) (P=0.30) in women with HSIL/carcinoma Pap results
In a low-risk cervical cancer screening population, increased HPV positivity by Cervista HPV testing in women with a NILM Pap test may result in a more frequent follow up for women with NILM Pap results. The efficacy of the Cervista HPV assay is marginally lower than that of HC2 in women with HSIL/carcinoma in a cancer surveillance population. Further studies are needed to delineate the efficacy of both Cervista and HC2 HPV assays in this population.