We verified the analytical performance of the Abbott RealTime SARS-CoV-2 assay on the m2000 system and compared its clinical performance to the CDC 2019-nCoV real-time PCR diagnostic panel and the Thermo Fisher TaqPath RT-PCR COVID-19 kit. We also performed a bridging study comparing the RealTime SARS-CoV-2 assay with the new Abbott Alinity m SARS-CoV-2 assay. A number of standards, reference materials, and commercially available controls were used for the analytical verification to confirm the limit of detection, linearity, and reproducibility. We used nasopharyngeal (NP) swab specimens collected in saline for the clinical verification and bridging studies. Overall, we found 91.2% positive percent agreement (PPA; 95% confidence interval [CI] = 76.2 to 98.14%) and a 100% negative percent agreement (NPA; 95% CI = 97.97 to 100%) between the results of the RealTime SARS-CoV-2 and CDC tests with 217 NP specimens (P = 0.13). We found a PPA of 100% (95% CI = 90.26 to 100%) and an NPA of 95.15% (95% CI = 83.47 to 99.4%) between the results of the RealTime and TaqPath tests with 77 NP specimens (P = 0.24). Finally, we tested 203 NP swab specimens for SARS-CoV-2 on the m2000 on the Alinity m systems. The PPA and NPA were 92.2% (95% CI = 85.3 to 96.59%) and 92% (95% CI = 84.8 to 96.5%), respectively (P = 0.4). Although cycle number (Cn) values obtained for the concordant positive samples were highly correlated (R² = 0.95), the Cn values were on average 14.14 higher on the Alinity m system due to the unread cycles with the RealTime SARS-CoV-2 assay.

中文翻译：

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雅培m2000和Alinity m系统上SARS-CoV-2分析性能的验证和确认

我们在m 2000系统上验证了Abbott RealTi m SARS-CoV-2分析的分析性能，并将其临床性能与CDC 2019-nCoV实时PCR诊断面板和Thermo Fisher TaqPath RT-PCR COVID-19进行了比较成套工具。我们还进行了一项桥接研究，比较了RealTi m SARS-CoV-2分析法和新型Abbott Alinity mSARS-CoV-2分析。许多标准物，参考材料和市售质控品都用于分析验证，以确认检测限，线性度和可重复性。我们将收集在盐水中的鼻咽（NP）拭子样本用于临床验证和桥接研究。总体而言，我们发现RealTi结果之间有91.2％的正百分比一致性（PPA； 95％的置信区间[CI] = 76.2至98.14％）和100％的负百分比一致性（NPA； 95％的CI = 97.97至100％）米ËSARS-CoV的-2和CDC试验用217 NP试样（P = 0.13）。我们发现100％的PPA（95％CI = 90.26％至100％）和RealTi的结果之间的95.15％的NPA（95％CI = 83.47〜99.4％）米e和TaqPath测试用77 NP标本（P = 0.24）。最后，我们在Alinity m系统上的m 2000上测试了203个NP拭子样本的SARS-CoV-2 。PPA和NPA分别为92.2％（95％CI = 85.3至96.59％）和92％（95％CI = 84.8至96.5％）（P = 0.4）。尽管从一致的阳性样本获得的循环数（Cn）值高度相关（R ² = 0.95），但是由于RealTi m e SARS-CoV-的未读循环，Alinity m系统的Cn值平均高出14.14。2测定。