Clinical validation of the Cervista® high-risk human papillomavirus test in Chinese women from Fujian province: a cross-sectional study

Therapeutics and Clinical Risk Management, Nov 2018

Clinical validation of the cervista® high-risk human papillomavirus test in Chinese women from Fujian province: a cross-sectional study Xiaodan Mao,1 Guanyu Ruan,1 Binhua Dong,1 Lihua Chen,1 Shuxia Xu,2 Fen Lin,1 Pengming Sun1,3 1Laboratory of Gynecologic Oncology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China; 2Department of Pathology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China; 3Department of Gynecology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China 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

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Clinical validation of the Cervista® high-risk human papillomavirus test in Chinese women from Fujian province: a cross-sectional study

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 Xiaodan Mao,1 Guanyu Ruan,1 Binhua Dong,1 Lihua Chen,1 Shuxia Xu,2 Fen Lin,1 Pengming Sun1,3 1Laboratory of Gynecologic Oncology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China; 2Department of Pathology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China; 3Department of Gynecology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China 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 Introduction Cervical cancer is the third most frequent cancer among women globally, especially in developing countries. It is estimated that there were 528,000 newly diagnosed cases and 265,653 deaths in 2012 worldwide.1 In China, the age-standardized incidence rate (ASIR) and mortality rate (ASMR) of cervical cancer were estimated at 10.3 and 2.6 per 100,000 women, respectively, in 2013; these rates are higher than those found in other developed countries.2 Cervical cancer has become one of the major health hazards for women. Fujian Province is on the southern coast of China, and the burden of cervical cancer is heavy there. Despite the successful implementation of cytopathologic screening programs, Chen et al estimate that 98,900 women will be diagnosed with cervical cancer, and 30,500 women died from the disease in China during 2015.3 In the beginning, HPV was used to triage abnormal cytology.4 Subsequently, in 2011, the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP) and the American Society for Clinical Pathology (ASCP) stated that in most clinical settings, women aged 30–65 years should be screened with co-testing.5 Recently, the Society of Gynecologic Oncology (SGO)/ASCCP guidelines propose to use HR-HPV testing alone as a primary screening way, which also recommend to use genotyping for HPV-16 and -18 to triage HR-HPV positive women.6 The benefits of HPV testing in primary cervical cancer screening have been demonstrated in several randomized controlled trials.7,8 A plethora of evidence indicates that high-risk human papillomaviruses (HR-HPVs) are important factors in cervical cancer.9,10 At present, the detection methods for HPV include Hybrid Capture 2 (HC2, Qiagen, Gaithersburg, MD, USA), Cervista® (Hologic, Bedford, MA, USA), Aptima (Hologic), Cobas (Roche, Pleasanton, CA, USA) and others.11 Early in 2009, HPV types were classified categorically as carcinogenic (Group 1), probably carcinogenic (Group 2A), possibly carcinogenic (Group 2B), not classifiable (Group 3), or probably not carcinogenic (Group 4) by the International Agency for Research on Cancer (IARC) Monog (...truncated)


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Xiaodan Mao, Guanyu Ruan, Binhua Dong, Lihua Chen, Shuxia Xu, Fen Lin, Pengming Sun. Clinical validation of the Cervista® high-risk human papillomavirus test in Chinese women from Fujian province: a cross-sectional study, Therapeutics and Clinical Risk Management, 2018, pp. 2243-2253, DOI: 10.2147/TCRM.S179334