Triage performance of PAX1 m /JAM3 m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Autor: Chen X; Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, 100730, China.; National Clinical Research Center for Obstetric & Gynecologic Diseases, Beijing, 100730, China.; State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, 100730, China., Jin X; Department of Medical Laboratory, Beijing Origin-Poly Bio-Tec Co., Ltd., Beijing, 102600, China., Kong L; Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, 100730, China.; National Clinical Research Center for Obstetric & Gynecologic Diseases, Beijing, 100730, China.; State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, 100730, China., Liou Y; Department of Medical Laboratory, Beijing Origin-Poly Bio-Tec Co., Ltd., Beijing, 102600, China.; Clinical Precision Medicine Research Center, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, 510062, China., Liu P; Department of Medical Laboratory, Beijing Origin-Poly Bio-Tec Co., Ltd., Beijing, 102600, China., Dong Z; Department of Obstetrics and Gynecology, Peking University International Hospital, Beijing, 100000, China., Zhou S; Department of Obstetrics and Gynecology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, 010000, China., Qi B; Department of Gynecology, Cangzhou Central Hospital, Cangzhou, 061000, China., Fei J; Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China., Chen X; Department of Obstetrics and Gynecology, Zhejiang Provincial People's Hospital, Hangzhou, 310000, China., Xiong G; Department of Obstetrics and Gynecology, Peking University International Hospital, Beijing, 100000, China., Hu Y; Department of Obstetrics and Gynecology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, 010000, China., Liu S; Department of Gynecology, Cangzhou Central Hospital, Cangzhou, 061000, China., Zhou J; Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China., Shou H; Department of Obstetrics and Gynecology, Zhejiang Provincial People's Hospital, Hangzhou, 310000, China., Li L; Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, 100730, China. lileigh@163.com.; National Clinical Research Center for Obstetric & Gynecologic Diseases, Beijing, 100730, China. lileigh@163.com.; State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, 100730, China. lileigh@163.com.
Jazyk: angličtina
Zdroj: Clinical epigenetics [Clin Epigenetics] 2024 Aug 16; Vol. 16 (1), pp. 108. Date of Electronic Publication: 2024 Aug 16.
DOI: 10.1186/s13148-024-01731-w
Abstrakt: Objectives: In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1 m /JAM3 m ) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +).
Methods: The triage performance of liquid-based cytology (LBC) and the PAX1 m /JAM3 m test for detecting CIN3 + were compared.
Results: In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1 m /JAM3 m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1 m /JAM3 m ( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1 m /JAM3 m (+). Compared with LBC ≥ ASCUS, PAX1 m /JAM3 m (+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1 m /JAM3 m (+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1 m /JAM3 m (+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8-100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7-26.8%).
Conclusions: In non-16/18 hrHPV(+) women, PAX1 m /JAM3 m was superior to cytology for detecting CIN3 + . Compared with LBC ≥ ASCUS, PAX1 m /JAM3 m (+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity.
(© 2024. The Author(s).)
Databáze: MEDLINE
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