Comparative performance and cycle threshold values of 10 nucleic acid amplification tests for SARS-CoV-2 on clinical samples.
Comparative performance and cycle threshold values of 10 nucleic acid amplification tests for SARS-CoV-2 on clinical samples.
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DOI：
10.1371/journal.pone.0252757
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Moriya K
中科院分区：
文献类型：
--
作者：
Mizoguchi M;Harada S;Okamoto K;Higurashi Y;Ikeda M;Moriya K
在日本，一些使用不同试剂的SARS-CoV-2核酸扩增试验(NAAT)已被批准用于临床。其中包括根据紧急使用授权通过简化程序批准的研究工具包，以稳定试剂的供应。虽然这些研究试剂盒已越来越多地用于临床实践，但临床环境下的诊断性能数据有限。我们使用日本批准的10个试剂盒(包括8个获得紧急使用授权的试剂盒)比较了NAAT获得的灵敏度、特异度和周期阈值(Ct值)，其中使用了69份冷冻保存的临床样本，其中包括23份不同Ct值的阳性样本和46份阴性样本。LightMix E基因检测冻存标本的病毒拷贝数为0.6~84521.1拷贝/μL，无一例假阳性(特异度：100%[95%CI，88.9%~100%])；以LightMix E基因检测为金标准，9种检测方法的敏感性分别为68.2%[95%CI，45.1%~86.1%]~95.5%[95%CI，77.2%~99.9%]。所有检测结果均为≥100Copes/μL阳性，即使在扩增相同基因区域(N1-CDC，N_2)的检测中，Ct值也有显著差异。在日本批准的NAAT中观察到诊断性能的差异。关于新出现的传染病诊断试剂盒，需要一个系统来确保试剂供应的快速和诊断的准确性。CT值有时被认为是传染性的标志，但通过不同的检测方法获得的CT值是不可互换的。
A number of nucleic acid amplification tests (NAATs) for SARS-CoV-2 with different reagents have been approved for clinical use in Japan. These include research kits approved under emergency use authorization through simplified process to stabilize the supply of the reagents. Although these research kits have been increasingly used in clinical practice, limited data is available for the diagnostic performance in clinical settings. We compared sensitivity, specificity, and cycle threshold (Ct) values obtained by NAATs using 10 kits approved in Japan including eight kits those receiving emergency use authorization using 69 frozen-stored clinical samples including 23 positive samples with various Ct values and 46 negative samples. Viral copy number of the frozen-stored samples determined with LightMix E-gene test ranged from 0.6 to 84521.1 copies/μL. While no false-positive results were obtained by any of these tests (specificity: 100% [95% CI, 88.9%-100%]), sensitivity of the nine tests ranged from 68.2% [95% CI, 45.1%-86.1%] to 95.5% [95% CI, 77.2%-99.9%] using LightMix E-gene test as the gold standard. All tests showed positive results for all samples with ≥100 copies/μL. Significant difference of Ct values even among tests amplifying the same genetic region (N1-CDC, N2) was also observed. Difference in the diagnostic performance was observed among NAATs approved in Japan. Regarding diagnostic kits for emerging infectious diseases, a system is needed to ensure both rapidity of reagent supply and accuracy of diagnosis. Ct values, which are sometimes regarded as a marker of infectivity, are not interchangeable when obtained by different assays.
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