Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2.
Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2.
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DOI：
10.1016/j.jcv.2020.104510
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发表时间：
2020-08
期刊：
影响因子：
--
通讯作者：
Molenkamp R
中科院分区：
文献类型：
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作者：
Iglói Z;Leven M;Abdel-Karem Abou-Nouar Z;Weller B;Matheeussen V;Coppens J;Koopmans M;Molenkamp R
商品化SARS-CoV-2 RT-PCR分析性能比较。13份SARS-CoV-2 RT-PCR的分析灵敏度在3.3-330个RNA拷贝之间。除1种方法外，其余方法的灵敏度均在参考方法的一个数量级以内。只有1种方法与另一种冠状病毒(MERS)发生交叉反应。武汉出现一种新型冠状病毒，中国引发了全球对准确诊断化验的需求。最初，大多数实验室开发的分子测试是可用的，但不久之后，不同的商业测试开始出现，而且数量仍在增加。虽然正在进行独立的业绩评价，但可用的数据仍然很少。在这里，我们提供了13种商业RT-PCR方法的关键性能特征的直接比较。选择了13种RT-PCR方法，依据的标准是它们可以遵循通用的RNA提取协议，在通用的PCR平台上使用和可用。使用10倍和2倍稀释系列的量化SARS-CoV-2细胞培养病毒库，与我们内部验证的检测结果进行了比较。用从培养的常见人类冠状病毒中提取的RNA检测特异性。除哨兵诊断B-E基因Ruo法(80%)外，本研究中包括的所有RT-PCR试剂盒的PCR效率均为90%。分析灵敏度在3.3个RNA拷贝到330个RNA拷贝之间变化。只有一项检测与另一种人类冠状病毒(MERS)发生交叉反应。这项研究提供了用于SARS-CoV-2检测的13种不同商业聚合酶链式反应分析的技术基线，有兴趣购买其中任何一种用于进一步全面临床验证的实验室可以使用这些方法。
Commercial SARS-CoV-2 RT-PCR analytical performance comparison. Analytical sensitivity of 13 SARS-CoV-2 RT-PCRs varied between 3.3–330 RNA copies. All but 1 assay had sensitivity within one order of magnitude of the reference assay. Only 1 assay cross reacted with another coronavirus (MERS). The emergence of a new coronavirus in Wuhan China has triggered a global need for accurate diagnostic assays. Initially, mostly laboratory developed molecular tests were available but shortly thereafter different commercial assays started to appear and are still increasing in number. Although independent performance evaluations are ongoing, available data is still scarce. Here we provide a direct comparison of key performance characteristics of 13 commercial RT-PCR assays. Thirteen RT-PCR assays were selected based on the criteria that they can be used following generic RNA extraction protocols, on common PCR platforms and availability. Using a 10-fold and 2-fold dilution series of a quantified SARS-CoV-2 cell-cultured virus stock, performance was assessed compared to our in house validated assay. Specificity was tested by using RNA extracted from cultured common human coronaviruses. All RT-PCR kits included in this study exhibited PCR efficiencies > 90%, except for the Sentinel Diagnostics B E-gene RUO assay (80%). Analytical sensitivity varied between 3.3 RNA copies to 330 RNA copies. Only one assay cross reacted with another human coronavirus (MERS). This study provides a technical baseline of 13 different commercial PCR assays for SARS-CoV-2 detection that can be used by laboratories interested in purchasing any of these for further full clinical validation.
影响因子：
19
作者：
Corman, Victor M.;Landt, Olfert;Drosten, Christian
通讯作者：
Drosten, Christian
DOI：
10.1016/j.jcv.2020.104432
发表时间：
2020-07-01
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
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作者：
Matheeussen, Veerle;Loens, Katherine;Ieven, Margareta
通讯作者：
Ieven, Margareta