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

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 populat...

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Detalles Bibliográficos
Autores principales: Mao, Xiaodan, Ruan, Guanyu, Dong, Binhua, Chen, Lihua, Xu, Shuxia, Lin, Fen, Sun, Pengming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6247958/
https://www.ncbi.nlm.nih.gov/pubmed/30532547
http://dx.doi.org/10.2147/TCRM.S179334
Descripción
Sumario: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.