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

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 (P<0.05), and showed a higher efficacy for detection of normal tissues and chronic cervicitis (P<0.05) and low-grade squamous intraepithelial lesions (LSILs) (P<0.05) than Aptima HPV E6/E7 mRNA test; while Aptima HPV E6/E7 mRNA test showed a greater detection of high-grade squamous intraepithelial lesions (HSILs) (P<0.05) and invasive cervical carcinoma than HPV DNA test. Aptima HPV E6/E7 mRNA test exhibited a higher specificity P<0.05), positive and negative prediction rates than HPV DNA test for detection of cervical lesions, and the sensitivity was comparable between the two tests (P>0.05). 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.