The occurrence of the COVID‐19 second‐wave outbreak in Europe has pushed laboratories performing molecular SARS‐CoV‐2 tests to increase their throughput and decrease the result rendering time. In this evaluation, we tested for the first time a new, extraction‐free, protocol with the Allplex SARS‐CoV‐2 Assay RT‐qPCR kit on a Nimbus platform. Ninety‐one samples, of which 71 previously tested positive with RT‐qPCR with extraction were immediately analyzed without extraction, using only a dilution and thermal shock protocol. The positive and negative percentage agreements were respectively 97.2% (95% confidence interval [CI]: 0.90–0.99) and 95.0% (95% CI: 0.76–0.99). The two false negatives observed were very weakly positive with the comparison method. Moderate variations in Ct of the targeted genes were observed (median ± 95% CI): E gene, +2.49 ± 0.44; N gene, +0.98 ± 0.54; RdRP/S genes, +2.64 ± 0.48. On the other hand, the number of tests performed within 24 h raised from 86.4% to 97.8%, the turn‐around time decreased from 19:18 to 09:03 (p < .0001), and the number of tests that can be performed per day doubled since this technique was introduced routinely in our laboratory.

中文翻译：

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开发和实施用于检测SARS-CoV-2及其对周转时间影响的RT-qPCR无提取协议

欧洲发生COVID-19第二波暴发已迫使实验室进行分子SARS-CoV-2测试，以提高其通量并减少结果渲染时间。在此评估中，我们首次在Nimbus平台上使用Allplex SARS-CoV-2 Assay RT-qPCR试剂盒测试了一种新的，无提取的实验方案。仅使用稀释和热休克方案，无需提取即可立即分析91个样品，其中71个先前通过RT-qPCR提取测试为阳性。正百分比协议和负百分比协议分别为97.2％（95％置信区间[CI]：0.90-0.99）和95.0％（95％CI：0.76-0.99）。用比较方法观察到的两个假阴性结果非常弱。观察到目标基因Ct的中等变化（中位数±95％CI）：E基因，+2.49±0。44; N基因，+ 0.98±0.54；RdRP / S基因，+ 2.64±0.48。另一方面，在24小时内执行的测试数量从86.4％增加到97.8％，周转时间从19:18减少到09:03（p  <.0001），并且自从我们实验室常规引入这项技术以来，每天可以执行的测试数量增加了一倍。