{"title":"基于杂交捕获技术的基因分型检测在中国宫颈癌筛查中的临床表现：一项基于人群的前瞻性多中心队列研究。","authors":"Jian Yin, Sumeng Wang, Shaokai Zhang, Wen Chen, Qinjing Pan, Xun Zhang, Xiaodong Cheng, Xibin Sun, Fanghui Zhao, Youlin Qiao","doi":"10.1016/j.cmi.2025.07.004","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines.</p><p><strong>Methods: </strong>A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.</p><p><strong>Results: </strong>At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], P<sub>McNemar[McN]</sub> = 0.004), and a marginally lower specificity (89.65% [95% CI: 89.01%-90.25%] vs. 91.61% [95% CI: 91.02%-92.15%], P<sub>McN</sub> <0.001) for detecting CIN2+. 7747 (82.6% follow-up rate) women completed the 3-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI: 87.77%-94.79%] vs. 63.56% [95% CI: 57.25%-59.44%], P<sub>McN</sub> <0.001), whereas both methods exhibited similar specificity (90.57% [95% CI: 89.89%-91.21%] vs. 91.37% [95% CI: 90.72%-91.99%], P<sub>McNr</sub> = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), p 0.294). In addition, individuals positive for HPV16/18 had a 3-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly >1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged ≥30 yielded similar results.</p><p><strong>Discussion: </strong>Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5000,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical performance of a genotyping assay based on a hybrid capture technique in cervical cancer screening in China: a prospective population-based multicentre cohort study.\",\"authors\":\"Jian Yin, Sumeng Wang, Shaokai Zhang, Wen Chen, Qinjing Pan, Xun Zhang, Xiaodong Cheng, Xibin Sun, Fanghui Zhao, Youlin Qiao\",\"doi\":\"10.1016/j.cmi.2025.07.004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines.</p><p><strong>Methods: </strong>A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.</p><p><strong>Results: </strong>At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], P<sub>McNemar[McN]</sub> = 0.004), and a marginally lower specificity (89.65% [95% CI: 89.01%-90.25%] vs. 91.61% [95% CI: 91.02%-92.15%], P<sub>McN</sub> <0.001) for detecting CIN2+. 7747 (82.6% follow-up rate) women completed the 3-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI: 87.77%-94.79%] vs. 63.56% [95% CI: 57.25%-59.44%], P<sub>McN</sub> <0.001), whereas both methods exhibited similar specificity (90.57% [95% CI: 89.89%-91.21%] vs. 91.37% [95% CI: 90.72%-91.99%], P<sub>McNr</sub> = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), p 0.294). In addition, individuals positive for HPV16/18 had a 3-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly >1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged ≥30 yielded similar results.</p><p><strong>Discussion: </strong>Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.</p>\",\"PeriodicalId\":10444,\"journal\":{\"name\":\"Clinical Microbiology and Infection\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.5000,\"publicationDate\":\"2025-07-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Microbiology and Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cmi.2025.07.004\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cmi.2025.07.004","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Clinical performance of a genotyping assay based on a hybrid capture technique in cervical cancer screening in China: a prospective population-based multicentre cohort study.
Objectives: We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines.
Methods: A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.
Results: At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], PMcNemar[McN] = 0.004), and a marginally lower specificity (89.65% [95% CI: 89.01%-90.25%] vs. 91.61% [95% CI: 91.02%-92.15%], PMcN <0.001) for detecting CIN2+. 7747 (82.6% follow-up rate) women completed the 3-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI: 87.77%-94.79%] vs. 63.56% [95% CI: 57.25%-59.44%], PMcN <0.001), whereas both methods exhibited similar specificity (90.57% [95% CI: 89.89%-91.21%] vs. 91.37% [95% CI: 90.72%-91.99%], PMcNr = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), p 0.294). In addition, individuals positive for HPV16/18 had a 3-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly >1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged ≥30 yielded similar results.
Discussion: Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.
期刊介绍：
Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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