Performance of human papillomavirus E6/E7 mRNA assay for primary cervical cancer screening and triage: Population-based screening in China

Jing Zhang; Di Yang; Xiaoli Cui; Guangcong Liu; Zhumei Cui; Chunyan Wang; Haozhe Piao

doi:10.3389/fcimb.2022.935071

Performance of human papillomavirus E6/E7 mRNA assay for primary cervical cancer screening and triage: Population-based screening in China

Front Cell Infect Microbiol. 2022 Aug 29:12:935071. doi: 10.3389/fcimb.2022.935071. eCollection 2022.

Authors

Jing Zhang¹, Di Yang¹, Xiaoli Cui¹, Guangcong Liu², Zhumei Cui³, Chunyan Wang¹, Haozhe Piao⁴

Affiliations

¹ Department of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.
² Department of Epidemiology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.
³ Department of Gynecology, Affiliated Hospital of Medical College, Qingdao University, Qingdao, China.
⁴ Department of Neurosurgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.

Abstract

Objective: Cervical cancer screening is very important in the prevention and treatment of cervical cancer. In China, the cervical screening strategy needs to be improved. To explore a suitable cervical screening strategy in China, we evaluated the performance of the human papillomavirus (HPV) E6/E7 mRNA (Aptima HPV (AHPV)) assay in primary screening and different triage strategies for women undergoing routine cervical screening.

Methods: A total of 10,002 women aged 35 to 65 years of age were recruited in Liaoning Province and Qingdao City, China. Specimens were tested by liquid-based cytology (LBC) and the AHPV assay, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all high-risk HPV (HR-HPV)-positive samples. Test characteristics were calculated based on histological review.

Results: We identified 109 women with high-grade squamous intraepithelial lesion or worse (HSIL+), including six with cervical cancer. The sensitivity of AHPV was clearly higher than that of LBC (92.7 [95% CI: 87.2, 97.2] vs. 67.9 [95% CI: 59.6, 76.1], p < 0.001). The specificity of AHPV was 93.0 (95% CI: 92.5, 93.5), which was lower than that of LBC (95.2 [95% CI: 94.8, 95.6], p < 0.001). There was no statistical difference between the positive predictive value of AHPV and LBC (13.5 [95% CI: 11.2, 16.2] vs. 14.3 [95% CI: 11.4, 17.6], p = 0.695). The difference of area under the curve (AUC) values between the AHPV test (0.928 [95% CI: 0.904, 0.953]) and LBC test (0.815 [95% CI: 0.771, 0.860]) in detecting HSIL+ was statistically significant (p < 0.001). Finally, among the three triage strategies, both the sensitivity (73.4 [95% CI: 65.1, 81.7]) and AUC (0.851 [95% CI: 0.809, 0.892]) of AHPV genotyping with reflex LBC triage were the greatest.

Conclusion: In summary, the AHPV assay is both specific and sensitive for detecting HSIL+ and may be suitable for use in primary cervical cancer screening in China. AHPV genotyping with reflex LBC triage may be a feasible triage strategy.

Keywords: Cervical screening; HPV E6/E7 mRNA; HR-HPV prevalence; cytology; triage.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Alphapapillomavirus*
China
Early Detection of Cancer
Female
Humans
Middle Aged
Papillomaviridae / genetics
Papillomavirus Infections* / diagnosis
RNA, Messenger / genetics
Triage
Uterine Cervical Neoplasms* / diagnosis

Substances

RNA, Messenger