论文标题
数字PCR高敏化COVID-19组测试
High-sensitivity COVID-19 group testing by digital PCR
论文作者
论文摘要
背景:随着越来越多的国家受到Covid-19的影响,全球对SARS-COV-2 RT-PCR测试的需求正在增加,并且由于测试仍然是包含该疾病传播的核心,这两种国家都在疾病正在出现的国家中以及在第一波潮流中的国家中,但暴露于重新出现。已经提出了小组测试作为扩大测试能力的解决方案,但是敏感性问题限制了其对大流行管理的影响。数字PCR(RT-DPCR)已被证明比RT-PCR更敏感,并且可以在这种情况下有所帮助。 Methods: We implemented RT-dPCR based COVID-19 group testing on commercially available system and assay (Naica System from Stilla Technologies) and investigated the sensitivity of the method in real life conditions of a university hospital in Paris, France, in May 2020. We tested the protocol in a direct comparison with reference RT-PCR testing on 448 samples split into groups of 3 sizes for RT-dPCR analysis: 56 groups of 8 samples, 28组16个样本和14组32个样本。 结果:单个RT-PCR测试确定了25个阳性样本。使用8组,RT-DPCR测试将23个组确定为阳性,对应于26个真实的阳性样品,其中包括2个未最初由单个RT-PCR检测到的样品,但通过进一步的RT-PCR和RT-DPCR研究证实了阳性。对于16个组,15组测试阳性,对应于25个真实的阳性样品。对于32组,但数据点有限的组发现100%的一致性。
Background: Worldwide demand for SARS-CoV-2 RT-PCR testing is increasing as more countries are impacted by COVID-19 and as testing remains central to contain the spread of the disease, both in countries where the disease is emerging and in countries that are past the first wave but exposed to re-emergence. Group testing has been proposed as a solution to expand testing capabilities but sensitivity concerns have limited its impact on the management of the pandemic. Digital PCR (RT-dPCR) has been shown to be more sensitive than RT-PCR and could help in this context. Methods: We implemented RT-dPCR based COVID-19 group testing on commercially available system and assay (Naica System from Stilla Technologies) and investigated the sensitivity of the method in real life conditions of a university hospital in Paris, France, in May 2020. We tested the protocol in a direct comparison with reference RT-PCR testing on 448 samples split into groups of 3 sizes for RT-dPCR analysis: 56 groups of 8 samples, 28 groups of 16 samples and 14 groups of 32 samples. Results: Individual RT-PCR testing identified 25 positive samples. Using groups of 8, testing by RT-dPCR identified 23 groups as positive, corresponding to 26 true positive samples including 2 samples not initially detected by individual RT-PCR but confirmed positive by further RT-PCR and RT-dPCR investigation. For groups of 16, 15 groups tested positive, corresponding to 25 true positive samples identified. 100% concordance is found for groups of 32 but with limited data points.