已发表论文

对中国福建省女性高危型人乳头瘤病毒进行 Cervista® 检测的临床验证:一个横断面研究

 

Authors Mao X, Ruan G, Dong B, Chen L, Xu S, Lin F, Sun P

Received 6 July 2018

Accepted for publication 17 October 2018

Published 16 November 2018 Volume 2018:14 Pages 2243—2253

DOI https://doi.org/10.2147/TCRM.S179334

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 2

Editor who approved publication: Professor Deyun Wang

Purpose: To estimate the high-risk human papillomavirus (HR-HPV) prevalence in a hospital-based population using the Cervista® and to determine the clinical value and significance of Cervista for cervical cancer screening in Fujian Province, China.
Patients and methods: In a hospital-based population, a total of 10,771 women from the Fujian Province were screened for cervical cancer and precancerous lesions using the thinprep cytologic test (TCT) and/or the Cervista. Women with HR-HPV infection and/or abnormal TCT were referred for colposcopy and biopsy. Pathological diagnosis was used as the gold standard.
Results: The overall HR-HPV prevalence was 16.57%. Among 10,229 cases, 976 had abnormal cytology results, of which, the HR-HPV positivity rate was 60.35% in this opportunistic screening population. The most common HR-HPV infection style was a simple infection. The most common species was A9 which was also the most prevalent species in all age. The women with CIN2+ (high-grade squamous intraepithelial lesion [HSIL]), especially cancer, were mostly concentrated in the age from 51 to 60 years old. The peak of CIN1 (low-grade squamous intraepithelial lesion, LSIL) prevalence was in the women aged 31–40. When using CIN1+, CIN2+ and CIN3+ as observed endpoints, the sensitivities were 86.07%, 92.73%, and 93.30% and negative likelihood ratio (NPV) were 99.15%, 99.75% and 99.83%, respectively. Cervista and TCT co-testing achieved the highest sensitivity and the lowest NLR.
Conclusion: The Cervista could be easily introduced in clinical practice in combination with TCT for cervical cancer screening in China. Patients with species A9 infection require a more actively clinical intervention.
Keywords: high-risk human papillomavirus, Cervista®, cytology, pathological diagnosis, cervical cancer




Figure 3 Prevalence of HR-HPV infection and a cervical lesion in different age stratification.