Role of HPV16/18/45 DNA testing of cervical specimens as a triage testing in cervical cancer screening

Objective: To evaluate the clinical performance of careHPV16/18/45 DNA testing of cervical specimens as a triage testing for women with positive findings during the cervical cancer screening. Methods: Eligible women aged 25-65 years were enrolled from two high-risk communities in Yangcheng County, Shanxi Province. After providing written informed consent on a voluntary base, women underwent questionnaire-based interview, gynecological examination, and sample collection. Hybrid capture 2 technology (HC2), careHPV, Avantage HPV E6 test, and visual inspection with acetic acid (VIA) were conducted as the primary screening tests at the enrollment visit. Women with any positive finding were invited to receive a second VIA and colposcopy, careHPV16/18/45 was performed as a triage testing. Any visible lesion under colposcopy was directly biopsied. Women with pathology confirmed cervical intraepithelial neoplasia grade 2 and worse (CIN2 +) were treated with standard procedures. Results: For the self-collected and doctor-collected samples, the application of careHPV16/18/45 as a triage testing decreased the colposcopy referral to 3.2% and 3.1%, respectively. Meanwhile, the sensitivity, specificity, and positive predictive value (PPV) for CIN2 + were 50.0%, 97.6%, and 26.7% for women with positive self-sampling careHPV results and 63.0%, 97.9%, and 34.0% for women with positive doctor-sampling careHPV results. Conclusion: careHPV16/18/45 is promising as a triage testing among women with positive screening findings in low-resource settings.