Performance of Aptima HPV E6/E7 mRNA Test for Detection of Cervical Lesions in a Large Chinese Population

Abstract

Background: We aimed to examine the effectiveness of Aptima HPV E6/E7 mRNA test for detection of cervical lesions in a large Chinese population. Methods: Overall, 4,350 women, who received simultaneously Aptima HPV E6/E7 mRNA test and HPV DNA test, followed by cervical biopsy in the Department of Gynecology of the Second Affiliated Hospital of Soochow University, Jiangsu Province, China from 2016-2020, were recruited. The detection of cervical lesions was compared between Aptima HPV E6/E7 mRNA test and HPV DNA test. Results: Overall, HPV DNA test exhibited a higher detection of all cervical lesions than Aptima HPV E6/E7 mRNA test (P0.05). Conclusion: Aptima HPV E6/E7 mRNA test gradually improves the detection of cervical lesions with disease severity, and shows a higher specificity, positive and negative prediction rates and comparable sensitivity for detection of clinical cervical lesions as compared with HPV DNA test.

Keywords

• Cervical lesion
• Screening
• Human papillomavirus DNA
• Diagnostic performance