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

Abstract

We aimed to examine the effectiveness of Aptima HPV E6/E7 mRNA test for detection of cervical lesions in a large Chinese population. 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. 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). 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.