Clin Lab. 2021 Jul 1;67(7). doi: 10.7754/Clin.Lab.2020.201025.
COVID-19 is caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), which was discovered in 2019 and spread around the world in a short time. SARS-CoV-2 nucleic acid amplification tests (NAATs) have been rapidly developed and quickly applied to clinical testing of COVID-19. Aim of this study was to evaluate the performance of four NAAT assays.
Limit of detection (LOD), precision, accuracy, analytical specificity and analytical interference studies on four NAATs (Daan, Sansure, Hybribio, and Bioperfectus) were performed according to Clinical Laboratory Standards Institute protocols and guidelines. The four NAATs were compared using 46 clinical samples.
The LOD of the N gene for Daan, Sansure, and Hybribio was 500 copies/mL, and that for Bioperfectus was 1,000 copies/mL. The LOD of the ORF1ab gene for Daan, Bioperfectus, and Hybribio was 3,000 copies/mL, and that for Sansure was 2,000 copies/mL. A good precision was shown at the concentration above 20% of the LOD for all four NAATs, with all individual coefficients of variation below 3.6%. Satisfactory results were also observed in the accuracy, analytical specificity, and analytical interference tests. The results of the comparison test showed that Daan, Sansure, and Hybribio NAATs could detect the samples with a specificity of 100% (30/30) and a sensitivity of 100% (16/16), whereas Bioperfectus NAAT detected the samples with a specificity of 100% (30/30) and a sensitivity of 81.25% (13/16). However, no significant difference in sensitivity was found between Bioperfectus NAAT and the three other NAATs (p > 0.05).
The four SARS-CoV-2 NAATs showed comparable performance, with the LOD of the N gene lower than the LOD of the ORF1ab gene.
COVID-19 是由严重急性呼吸系统综合症冠状病毒-2（SARS-CoV-2）引起的，该病毒于 2019 年被发现，并在短时间内在全球范围内传播。SARS-CoV-2 核酸扩增检测（NAATs）已迅速开发并迅速应用于 COVID-19 的临床检测。本研究旨在评估四种 NAAT 检测方法的性能。
根据临床实验室标准协会的协议和指南，对四种 NAAT（Daan、Sansure、Hybribio 和 Bioperfectus）进行了检测限（LOD）、精密度、准确性、分析特异性和分析干扰研究。使用 46 个临床样本对这四种 NAAT 进行了比较。
Daan、Sansure 和 Hybribio 的 N 基因 LOD 为 500 拷贝/mL，Bioperfectus 的 LOD 为 1000 拷贝/mL。Daan、Bioperfectus 和 Hybribio 的 ORF1ab 基因 LOD 为 3000 拷贝/mL，Sansure 的 LOD 为 2000 拷贝/mL。在所有四种 NAAT 中，当浓度高于 LOD 的 20%时，均显示出良好的精密度，所有单个变异系数均低于 3.6%。在准确性、分析特异性和分析干扰试验中也观察到了令人满意的结果。比较试验结果表明，Daan、Sansure 和 Hybribio NAAT 能够以 100%（30/30）的特异性和 100%（16/16）的敏感性检测样本，而 Bioperfectus NAAT 以 100%（30/30）的特异性和 81.25%（13/16）的敏感性检测样本。然而，Bioperfectus NAAT 与其他三种 NAAT 之间的敏感性无显著差异（p>0.05）。
四种 SARS-CoV-2 NAAT 表现出相当的性能，N 基因的 LOD 低于 ORF1ab 基因的 LOD。
