The increasing COVID-19 widespread has created the necessity to assess the diagnostic accuracy of newly introduced (RT-PCR based) assays for SARS-CoV-2 RNA detection in respiratory tract samples. We compared the results of the Allplex™ 2019-nCoV assay with those of the Simplexa™ COVID-19 Direct assay and the Quanty COVID-19 assay, respectively, all performed on 125 nasal/oropharyngeal swab samples of patients with COVID-19 suspicion. Fifty-four samples were positive, and 71 were negative with the Allplex™ assay, whereas 47 of 54 samples were also positive with the Simplexa™ assay. The Quanty assay detected 55 positive samples, including the 54 positive samples with the Allplex™ assay and 1 sample that was Allplex™ negative but Simplexa™ positive. Using a consensus result criterion as the reference standard allowed to resolve the eight samples with discordant results (one Allplex™ negative and seven Simplexa™ negative) as truly false negative. Interestingly, a Spearman’s negative association was found between the viral RNA loads quantified by the Quanty assay and the C_T values of RT PCRs performed with either the Allplex™ assay or the Simplexa™ assay. However, the strength of this association was higher for the Allplex™ assay (N gene, ρ = − 0.92; RdRP gene, ρ = − 0.91) than for the Simplexa™ assay (ORF1ab gene, ρ = − 0.65; S gene, ρ = − 0.80). The Allplex™ 2019-nCoV, the Simplexa™ COVID-19 Direct, and the Quanty COVID-19 assays yielded comparable results. However, the role these assays might play in future clinical practice warrants larger comparison studies.

COVID-19 的日益广泛传播使得有必要评估新引入的（基于 RT-PCR 的）呼吸道样本中 SARS-CoV-2 RNA 检测方法的诊断准确性。我们将 Allplex™ 2019-nCoV 检测的结果分别与 Simplexa™ COVID-19 Direct 检测和 Quanty COVID-19 检测的结果进行了比较，所有这些检测均对疑似 COVID-19 的患者的 125 份鼻/口咽拭子样本进行。Allplex™ 检测结果显示，54 个样本呈阳性，71 个样本呈阴性，而 Simplexa™ 检测结果显示，54 个样本中的 47 个样本呈阳性。Quanty 检测检测到 55 个阳性样本，其中包括 Allplex™ 检测的 54 个阳性样本和 Allplex™ 阴性但 Simplexa™ 阳性的 1 个样本。使用一致的结果标准作为参考标准，可以将结果不一致的八个样本（一个 Allplex™ 阴性和七个 Simplexa™ 阴性）解析为真正的假阴性。有趣的是，通过 Quanty 测定定量的病毒 RNA 载量与使用 Allplex™ 测定或 Simplexa™ 测定进行的 RT PCR 的 CT 值_之间发现了 Spearman 负关联。然而，Allplex™ 检测（N 基因， ρ  = − 0.92；RdRP 基因，ρ = − 0.91）的这种关联强度高于 Simplexa™ 检测（ORF1ab 基因，ρ = − 0.65；S 基因， ρ  = − 0.65） = − 0.80）。Allplex™ 2019-nCoV、Simplexa™ COVID-19 Direct 和 Quanty COVID-19 检测得出了类似的结果。然而，这些测定在未来临床实践中可能发挥的作用需要进行更大规模的比较研究。