Capital Medical University Beijing Tongren Hospital, Beijing, China.
Fudan University Huanshan Hospital North, Shanghai, China.
J Low Genit Tract Dis. 2021 Jan 1;25(1):22-26. doi: 10.1097/LGT.0000000000000577.
The aim of the study was to evaluate the Cobas 4800 Assay and the SeqHPV Assay with self (S) and direct (D) cervical samples in the Chinese Multicenter Screening Trial (CHIMUST).
The CHIMUST is a large population-based multicenter clinical trial, and 10,885 women aged 30-59 years from 15 sites in 7 provinces with no cervical cancer screening for 3 years were eligible. All participating women contributed one self-collected sample (S) and 1 physician-collected endocervical sample (DL). The self-collected sample was first applied to the solid media transport card (SS), and then, the brush placed in 6 mL of ThinPrepSolution (SL). All samples were tested with Cobas 4800 and SeqHPV high-risk HPV assays. Patients human papillomavirus positive (self or direct) were recalled for colposcopy and biopsies.
A total of 10,399 women had complete data. The mean age was 43.9 years. A total of 1.4% (142/10,399) had cervical intraepithelial neoplasia (CIN) 2+ and 0.5% (54/10,339) had CIN 3+. In the liquid specimens, the overall HPV infection rates were 10.8% for Cobas and 10.9% for SeqHPV in D sample, and 13.7% for Cobas and 11.6% for SeqHPV in SL sample, respectively. The sensitivity of Cobas-DL, Cobas-SL, SeqHPV-DL, and SeqHPV-SL for CIN 2+ was 95.07%, 95.07%, 94.33%, and 96.48%, respectively. The specificity of Cobas-DL, Cobas-SL, SeqHPV-DL, and SeqHPV-SL for CIN 2+ was 90.38%, 87.35%, 90.21%, and 89.53%, respectively. There were no differences in sensitivity when applying the 2 assays to both self- and directly collected samples in liquid transport media (p > .05).
Both Cobas and SeqHPV screening assays using both self-collected and directly endocervical collected specimens demonstrate similar sensitivity for the detection of CIN 2+ and CIN 3+.
本研究旨在评估 Cobas 4800 检测法和 SeqHPV 检测法在 15 个地点的中国多中心筛查试验（CHIMUST）中对自我（S）和直接（D）宫颈样本的检测效果。
CHIMUST 是一项大型基于人群的多中心临床试验，来自 7 个省的 15 个地点的 10885 名年龄在 30-59 岁之间、3 年内未接受过宫颈癌筛查的妇女符合条件。所有参与的妇女均提供了一份自我采集样本（S）和一份医生采集的宫颈内样本（DL）。自我采集的样本首先应用于固体介质转运卡（SS），然后将刷子放入 6 毫升的 ThinPrepSolution（SL）中。所有样本均采用 Cobas 4800 和 SeqHPV 高危型 HPV 检测法进行检测。自我或直接检测出人乳头瘤病毒阳性的患者召回行阴道镜检查和活检。
共有 10399 名妇女完成了完整的数据收集。平均年龄为 43.9 岁。共有 1.4%（142/10399）的妇女患有宫颈上皮内瘤变（CIN）2+，0.5%（54/10339）的妇女患有 CIN 3+。在液体标本中，Cobas 检测法对 D 样本的总体 HPV 感染率为 10.8%，SeqHPV 检测法为 10.9%，Cobas 检测法对 SL 样本的总体 HPV 感染率为 13.7%，SeqHPV 检测法为 11.6%。Cobas-DL、Cobas-SL、SeqHPV-DL 和 SeqHPV-SL 对 CIN 2+的敏感度分别为 95.07%、95.07%、94.33%和 96.48%。Cobas-DL、Cobas-SL、SeqHPV-DL 和 SeqHPV-SL 对 CIN 2+的特异度分别为 90.38%、87.35%、90.21%和 89.53%。在液体转运介质中，两种检测法对自我采集和直接采集样本的应用在敏感度上没有差异（p＞.05）。
Cobas 和 SeqHPV 筛查检测法在对自我采集和直接采集的宫颈样本的检测中，对 CIN 2+和 CIN 3+的检测效果相似。
