对用于高危型人乳头瘤病毒检测及自我采集样本宫颈癌筛查的固体与液体运输介质的评估。
An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens.
作者信息
Du Hui, Duan Xianzhi, Liu Yan, Shi Bin, Zhang Wei, Wang Chun, Qu Xinfen, Bao Juncui, Li Jingran, Zhao Chao, Jiang Jing, Liu Juan, Wu Kejia, Xiao Aimin, Duan Lvfang, Huang Xia, Bian Shuhuang, Zhang Lijie, Luo Hongxue, Wei Lihui, Belinson Jerome L, Wu Ruifang
机构信息
Peking University Shenzhen Hospital, Shenzhen, PR China.
Capital Medical University Beijing Tongren Hospital, Beijing, PR China.
出版信息
Infect Agent Cancer. 2020 Nov 30;15(1):72. doi: 10.1186/s13027-020-00333-4.
BACKGROUND
The solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the self-collection we used a pseudo-self-collection technique. The current study expands this prior work using true self-collections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in self-samples compared to liquid transport media.
METHODS
Ten thousand eight hundred eighty-five women between the ages of 30-59 with no screening for 3 years were enrolled. The self-collected sample was first applied to a new solid media transport card (Labeled as SC) then the brush placed in 6 ml ThinPrep liquid (Labeled as SL). Then a physician collected a direct endocervical specimen into ThinPrep liquid (Labeled as DL). Samples were tested with Cobas 4800 and the SeqHPV NGS assay for HR-HPV. Patients positive on any test were recalled for colposcopy and biopsy.
RESULTS
Ten thousand three hundred thirty-nine participants had complete data. The mean age was 43.9 years. CIN 2+ rates were 1.4% (142/10339). The agreement in HPV detection between the two different self-sample collection media was also good (Cobas HPV kappa = 0.86; SeqHPV kappa = 0.98). Tested with Cobas, the sensitivity of Cobas-SL and Cobas-SC for CIN 2+ was95.07 and 94.37%; and for CIN3+ was 96.30, 96.30% respectively. The specificity of Cobas-SC, and Cobas-SL for CIN2+ was 88.74 and 87.35%; for CIN3 was 88.04and 86.65% respectively. Tested with SeqHPV, the sensitivity for CIN2+ of Seq-SC and Seq-SL was 95.77 and 96.48%; for CIN3+, both the SC and SL specimens had a sensitivity of 100%. The specificity for CIN2+ of Seq-SC and Seq-SL was 89.54 and 89.53%; for CIN3+ was 88.84,88.82% respectively. For both HR-HPV assays, the sensitivities were similar for the two self-sample media (SC vs SL, p = 1.00).
CONCLUSIONS
The solid transport card for collecting vaginal self-samples as accurate as liquid transport media assayed by two different PCR based HR-HPV tests. The solid transport media is a suitable medium for collecting and storing vaginal self-samples.
背景
固体运输介质是一种小尺寸卡片，可从多种生物样本中快速、轻松地提取DNA。2016年我们开发了一种固体介质运输卡；在该初步研究中，为了控制自我采样，我们使用了一种假自我采样技术。当前研究扩展了这项先前的工作，采用真正的自我采样且仅使用POI卡，旨在评估固体介质运输卡与液体运输介质相比在自我采样中检测高危型人乳头瘤病毒（HR-HPV）的效果。
方法
招募了10885名年龄在30至59岁之间、3年未进行筛查的女性。自我采集的样本首先应用于新的固体介质运输卡（标记为SC），然后将刷子放入6毫升ThinPrep液体（标记为SL）中。然后医生采集直接宫颈管内样本放入ThinPrep液体（标记为DL）。样本用Cobas 4800和SeqHPV二代测序检测法检测HR-HPV。任何检测呈阳性的患者都被召回进行阴道镜检查和活检。
结果
10339名参与者有完整数据。平均年龄为43.9岁。2级及以上宫颈上皮内瘤变（CIN 2+）发生率为1.4%（142/10339）。两种不同自我采样采集介质在HPV检测方面的一致性也很好（Cobas HPV卡帕值=0.86；SeqHPV卡帕值=0.98）。用Cobas检测时，Cobas-SL和Cobas-SC对CIN 2+的敏感性分别为95.07%和94.37%；对CIN3+的敏感性分别为96.30%、96.30%。Cobas-SC和Cobas-SL对CIN2+的特异性分别为88.74%和87.35%；对CIN3的特异性分别为88.04%和86.65%。用SeqHPV检测时，Seq-SC和Seq-SL对CIN2+的敏感性分别为95.77%和96.48%；对CIN3+，SC和SL样本的敏感性均为100%。Seq-SC和Seq-SL对CIN2+的特异性分别为89.54%和89.53%；对CIN3+的特异性分别为88.84%、88.82%。对于两种HR-HPV检测方法，两种自我采样介质的敏感性相似（SC与SL相比，p = 1.00）。
结论
用于收集阴道自我采样的固体运输卡与通过两种基于不同PCR的HR-HPV检测法检测的液体运输介质一样准确。固体运输介质是收集和储存阴道自我采样的合适介质。
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