Molecular Biomarkers & Diagnosis

A Real-World Feasibility Study of CareHPV assay, VIA/VILI and Pap Smear as Primary Screening in Rural China

Abstract

Yuqian Zhao, Le Dang, Shaokai Zhang, Xiaofeng Hu, Tingting Zuo, Feng Chen, Xun Zhang, Wen Chen and Youlin Qiao

Background: To compare the real-world performance of visual inspection with acetic acid and with Lugol’s iodine (VIA/VILI), cytology and careHPV DNA assay in rural China performed by local health providers.

Methods: Eligible women living in rural areas in Xinmi County, Henan Province were invited to participate in cervical cancer screening program. Enrolled women were randomized into 3 intervention arms, screened by VIA/ VILI, pap smears, and careHPV assay respectively. Women had positive primary screening results were referred to colposcopy and/or biopsy. All the clinical and lab work was performed by local health providers. The final diagnoses of histopathology were based on the diagnosing of a senior histopathology expert from Cancer Hospital, Chinese Academy of Medical Sciences. Questionnaires about the knowledge and attitudes towards the HPV and the screening program of the health providers at village clinics were collected.

Results: 894 women had careHPV DNA test, 552 underwent VIA/VILI and 547 had Pap smears. The positive rates for careHPV assay, VIA/VILI and Pap smears were 10.6%, 18.1%, and 4.9% respectively (χ2=48.647, P<0.001). The overall CIN2+ detection rate was 0.5%, the CIN2+ detection rate for the three arms were not significantly different (0.7% for careHPV assay, 0.5% for VIA/VILI, 0.2% for pap smear, χ2=1.648, P=0.439). The knowledge of the health providers about HPV, HPV assay in screening was unsatisfactory. However, their attitudes about implementing HPV assay into the national program were positive.

Conclusion: Implementing careHPV assay in low resource settings and performed by simply trained lab personnel is feasible. For large population screening program, extensive training and good quality control are needed to improve the quality. Education for implementing HPV assay in local health providers are needed.