ABSTRACT

Objective

To compare the accuracy parameters of seven commercial molecular in vitro diagnostic tests for detecting SARS-CoV-2.

Methods

Studies evaluating the accuracy of seven different commercial molecular diagnostic tests for detecting SARS-CoV-2 (Cepheid Xpert Xpress SARS-CoV-2 test, Simplexa COVID-19 Direct, Abbott ID NOW COVID-19, Cobas SARS-CoV-2, Allplex 2019-nCoV Assay, Panther Fusion SARS-CoV-2, and BioFire COVID-19 Test) were included. The quality of the included studies was assessed using the QUADAS-2 checklist. A bivariate random-effects regression model was implemented.

Results

Meta-analysis of 12 included studies showed that the performances of commercial COVID-19 molecular in vitro diagnostic tests were high, with a summary sensitivity of 95.9% (95% CI 93.9–97.2%, I² = 60.22%) and specificity of 97.2% (95% CI 95.5–98.3%, I² = 56.66%). Among seven evaluated tests, the Abbott ID NOW COVID-19 and Simplexa COVID-19 Direct displayed lower sensitivity (91.6%, 95% CI 80.5–96.6% and 92%, 95% CI 86.2–95.5, respectively).

Conclusion

All evaluated tests showed good accuracy. However, the slightly lower sensitivity observed in the Abbott ID Now COVID-19 and Simplexa COVID-19 Direct should be considered when deciding on a test platform. Moreover, the diagnostic accuracy of COVID-19 commercial diagnostic tests should be weighed against their ease of use and speed.

中文翻译：

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七种商业分子体外 SARS-CoV-2 检测测试的诊断准确性：快速荟萃分析

 抽象的

 客观的

比较用于检测 SARS-CoV-2 的七种商业分子体外诊断测试的准确性参数。

 方法

研究评估了七种不同的商业分子诊断测试检测 SARS-CoV-2 的准确性（Cepheid Xpert Xpress SARS-CoV-2 测试、Simplexa COVID-19 Direct、Abbott ID NOW COVID-19、Cobas SARS-CoV-2、Allplex包括 2019-nCoV 检测、Panther Fusion SARS-CoV-2 和 BioFire COVID-19 检测）。使用 QUADAS-2 检查表评估纳入研究的质量。实施了双变量随机效应回归模型。

 结果

对 12 项纳入研究的荟萃分析表明，商业化的 COVID-19 分子体外诊断测试的性能很高，总体敏感性为 95.9%（95% CI 93.9–97.2%， I ² = 60.22%），特异性为 97.2 %（95% CI 95.5–98.3%， I ² = 56.66%）。在七项评估的测试中，Abbott ID NOW COVID-19 和 Simplexa COVID-19 Direct 显示出较低的敏感性（分别为 91.6%、95% CI 80.5–96.6% 和 92%、95% CI 86.2–95.5）。

 结论

所有评估的测试都显示出良好的准确性。然而，在决定测试平台时，应考虑 Abbott ID Now COVID-19 和 Simplexa COVID-19 Direct 中观察到的稍低的灵敏度。此外，应权衡 COVID-19 商业诊断测试的诊断准确性及其易用性和速度。