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.

中文翻译：

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对自采集标本进行高危HPV检测和宫颈癌筛查的固体与液体转运介质的评价

背景 固体传输介质是一种小尺寸卡片，可以快速、轻松地从各种生物样品中提取 DNA。2016年开发出固态媒体传输卡；对于控制自我收集的试点研究，我们使用了一种伪自我收集技术。当前的研究使用真实的自我收集和仅 POI 卡扩展了这项先前的工作，旨在评估固体培养基运输卡与液体运输培养基相比检测自我样品中的 HR-HPV。方法 一万八百八十五名年龄在 30-59 岁之间、3 年内未进行筛查的女性。自收集样品首先应用于新的固体培养基运输卡（标记为 SC），然后将刷子置于 6 ml ThinPrep 液体（标记为 SL）中。然后医生将直接宫颈管标本收集到 ThinPrep 液体（标记为 DL）中。样品用 Cobas 4800 和 SeqHPV NGS 检测检测 HR-HPV。任何测试呈阳性的患者被召回进行阴道镜检查和活检。结果一万三百三十九名参与者拥有完整的数据。平均年龄为 43.9 岁。CIN 2+ 率为 1.4% (142/10339)。两种不同的自样本采集介质之间 HPV 检测的一致性也很好（Cobas HPV kappa = 0.86；SeqHPV kappa = 0.98）。用Cobas测试，Cobas-SL和Cobas-SC对CIN 2+的灵敏度分别为95.07和94.37%；CIN3+ 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%；CIN3 分别为 88.04 和 86.65%。用 SeqHPV 测试，Seq-SC和Seq-SL对CIN2+的灵敏度分别为95.77%和96.48%；对于 CIN3+，SC 和 SL 标本的灵敏度均为 100%。Seq-SC和Seq-SL对CIN2+的特异性分别为89.54%和89.53%；CIN3+ 分别为 88.84、88.82%。对于两种 HR-HPV 检测，两种自样本培养基的敏感性相似（SC 与 SL，p = 1.00）。结论 用于收集阴道自体样本的固体运输卡与通过两种不同的基于 PCR 的 HR-HPV 测试测定的液体运输介质一样准确。固体运输介质是用于收集和储存阴道自体样品的合适介质。两种自采样介质的灵敏度相似（SC 与 SL，p = 1.00）。结论 用于收集阴道自体样本的固体运输卡与通过两种不同的基于 PCR 的 HR-HPV 测试测定的液体运输介质一样准确。固体运输介质是用于收集和储存阴道自体样品的合适介质。两种自采样介质的灵敏度相似（SC 与 SL，p = 1.00）。结论 用于收集阴道自体样本的固体运输卡与通过两种不同的基于 PCR 的 HR-HPV 测试测定的液体运输介质一样准确。固体运输介质是用于收集和储存阴道自体样品的合适介质。