The clinical performance of high risk HPV DNA test among triage women with cytology showing atypical squamous cells of undetermined significance

Abstract

Objective: To evaluate the performance of high risk human papillomavirus (HR-HPV) DNA test for triage ASC-US in Chinese population. Methods: The study population was from Jiyuan city in Henan Province where a cervical cancer screening cohort (4 026 women) was set up from April to July in 2017. Women with ASC-US and complete recall information of colposcope were selected as the study objects. Self-designed questionnaire was used to survey the general information and medical history of cervical cancer, thencervical cytological speciments were collected for cytodiagnosis and HPV DNA test, followed by colposcopy, lesion biopsy and histology diagnose. The diagnosis of histology was used as the gold standard. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as well as corresponding 95% confidential interval (CI) were calculated. Results: The average age of the included 393 women with ASC-US were (50.81±9.22) years old. The positivity of high risk human papillomavirus (HR-HPV), HPV16 and HPV18 were 35.6%, 10.69% and 2.80%, respectively. The sensitivity, specificity, PPV and NPV for HR-HPV to detect CIN2+ were 84.38% (68.25%-93.14%), 68.70% (63.74%-73.26%), 19.29% (13.61%-26.61%) and 98.02% (95.46%-99.15%). When compared with HR-HPV, HPV16/18 had a lower sensitivity (59.38% (42.26%-74.48%)) and a higher specificity(91.14% (87.75%-93.65%)), the PPV and NPV were 59.38% (25.32%-50.98%) and 91.14% (93.61%-97.77%). Conclusion: It was more effective for HR-HPV to triage ASC-US than HPV16/18. In order to improve the effect of HPV16/18, it should include more HR-HPV types which were more prevalent in Chinese population.