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.

IF 8.5 1区医学 Q1 INFECTIOUS DISEASES

Clinical Microbiology and Infection Pub Date : 2025-07-14 DOI:10.1016/j.cmi.2025.07.004

Jian Yin, Sumeng Wang, Shaokai Zhang, Wen Chen, Qinjing Pan, Xun Zhang, Xiaodong Cheng, Xibin Sun, Fanghui Zhao, Youlin Qiao

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引用次数: 0

Abstract

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%], P_McNemar[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%], P_McN <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_McN <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_McNr = 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.

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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。

目的：我们旨在评估DH3的临床表现，DH3是一种混合捕获方法，可分别检测人乳头瘤病毒（HPV） 16/18和其他12种HPV类型，用于普通人群宫颈癌的初级筛查，遵循中国指南。方法：来自3个中心的9379名年龄在21-64岁的符合条件的女性接受了DH3和液体细胞学（LBC）的基线筛查，随后随访3年。评估HPV检测（DH3）和lbc的诊断性能，包括敏感性、特异性、阳性预测值（绝对风险）和阴性预测值，用于检测宫颈上皮内瘤变2级及以上（CIN2+）病变。结果：在基线时，146名（1.56%）参与者被确定为CIN2+病变。与LBC合并反射性HR-HPV相比，原发性HR-HPV合并反射性LBC检测CIN2+的敏感性（95.89% [95% CI, 91.33-98.10%]对84.93% [95% CI, 78.24-89.83%], PMcNemar = 0.004）明显更高，特异性（89.65% [95% CI, 89.01-90.25%]对91.61% [95% CI, 91.02-92.15%], PMcNemar < 0.001）略低。7747名（随访率82.6%）女性完成了为期三年的随访，其中236名（3.00%）累计诊断为CIN2+。HR-HPV合并反射性LBC的敏感性明显高于LBC合并反射性HR-HPV的敏感性（91.95% [95% CI, 87.77-94.79%]对63.56% [95% CI, 57.25-69.44%], PMcNemar < 0.001），而两种方法对CIN2+的特异性相似（90.57% [95% CI, 89.89-91.21%]对91.37% [95% CI, 90.72-91.99%], PMcNemar = 0.062）。两种方法的阴道镜转诊率也具有可比性(5.77% （447/7747)vs. 5.38% (417/7747), P = 0.294）。此外，HPV16/18阳性个体的三年CIN2+绝对风险超过48%。相比之下，hpv阴性人群的风险仅为0.28%(19/6822)，显著低于细胞学正常人群的1.24%（86/6949）。将分析对象限制在30岁及以上的女性身上，也得到了类似的结果。结论：我们的研究表明DH3在宫颈筛查中表现出可靠的临床表现。经过验证的HPV检测有望提高以人群为基础的筛查的质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Microbiology and Infection 医学-传染病学

CiteScore

25.30

自引率

2.10%

发文量

441

审稿时长

2-4 weeks

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.