Abstract
OBJECTIVE: To evaluate the polymerase chain reaction (PCR)-reverse-dot-blot (RDB) human papillomavirus (HPV) genotyping test as a feasible assay for the cervical cancer primary screening. METHODS: In a hospital-based cohort, a total of 21,568 women were voluntarily enrolled from March 2009 to November 2016 for evaluating the 3 current cervical cancer screening strategies: co-test, cytology primary and high-risk HPV (HR-HPV) primary by using PCR-RDB HPV genotyping and liquid-based cytology (thinprep cytologic test [TCT]). Women with HR-HPV infection and/or abnormal cytology were referred for colposcopy, and the biopsy or conization was performed according to the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines. RESULTS: Overall, 18.20% (3,935/21,568) of the women were detected as HR-HPV-positive, 5.04% (1,088/21,568) were diagnosed with cervical intraepithelial neoplasia 2 or higher (CIN2+), and 3.43% (739/21,568) with CIN3+. The cumulative incidence rates for CIN2+/CIN3+ in patients with HPV-16/18-positive were 48.28%/37.20%, while they were 0.86%/0.38%, 0.30%/0.15% and 0.18%/0.09% in cytology-negative, HR-HPV-negative and co-test-negative population, respectively. Using CIN2+ and CIN3+ as the observed endpoints, the sensitivity and negative predictive value (NPV) of HR-HPV genotyping as a primary screening tool were 90.99%/99.49% and 91.57%/99.80%. Moreover, using HR-HPV genotyping primary screening could detect the same more CIN2+/CIN3+ cases in baseline-detection as co-testing (990/700 vs. 991/701) and far more than cytology primary screening (903/656, p<0.05). It also achieved the lowest misdiagnosis rate (8.01%/5.02%). Although HPV genotyping primary screening required an increased number of colposcopies (2.75/3.89 per CIN2+/CIN3+ case), it yielded an acceptable rate. CONCLUSIONS: The PCR-RDB HPV genotyping test is a cost-effective and beneficial cervical cancer primary screening for hospital-based opportunistic screening.