Department of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South Korea.
Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
J Med Virol. 2021 Jul;93(7):4523-4531. doi: 10.1002/jmv.26994. Epub 2021 May 3.
Rapid and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is essential to prevent the spread of the virus. We investigated the diagnostic accuracy of the Xpert Xpress and the ID NOW assays for rapid detection of SARS-CoV-2 using a systemic review and meta-analysis approach. A systematic literature search was performed using PubMed, Embase, and the Cochrane COVID-19 Study Register. The sensitivity and specificity of these tests for detecting viruses in patients with suspected SARS-CoV-2 infection were pooled. We used commercial and laboratory-developed reverse transcription-polymerase chain reactions as reference standards. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to assess the risk of bias. We identified 11 studies involving 1734 subjects for the Xpert Xpress assay and 10 studies involving 1778 subjects for the ID NOW assay. The pooled sensitivity and specificity of the Xpert Xpress assay for detection of SARS-CoV-2 were 0.99 (95% confidence interval [CI], 0.97 to 0.99) and 0.97 (95% CI, 0.95 to 0.98), respectively. The pooled sensitivity and specificity of the ID NOW assay were 0.79 (95% CI, 0.69 to 0.86) and 1.00 (95% CI, 0.98 to 1.00), respectively. The studies included in our analysis seemed to have low methodological quality. The Xpert Xpress assay showed excellent diagnostic accuracy for rapid detection of SARS-CoV-2. However, as the ID NOW assay showed relatively low sensitivity, this test might miss several positive samples.
快速准确地诊断严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 感染对于防止病毒传播至关重要。我们采用系统评价和荟萃分析的方法,研究了 Xpert Xpress 和 ID NOW 检测试剂盒快速检测 SARS-CoV-2 的诊断准确性。我们使用 PubMed、Embase 和 Cochrane COVID-19 研究注册库进行了系统文献检索。汇总了这些检测方法用于检测疑似 SARS-CoV-2 感染患者病毒的敏感性和特异性。我们使用商业和实验室开发的逆转录聚合酶链反应作为参考标准。采用诊断准确性研究质量评估-2 工具评估偏倚风险。我们确定了 11 项研究,涉及 1734 例使用 Xpert Xpress 检测试剂盒的患者,10 项研究涉及 1778 例使用 ID NOW 检测试剂盒的患者。Xpert Xpress 检测试剂盒检测 SARS-CoV-2 的汇总敏感性和特异性分别为 0.99(95%置信区间 [CI],0.97 至 0.99)和 0.97(95% CI,0.95 至 0.98)。ID NOW 检测试剂盒的汇总敏感性和特异性分别为 0.79(95% CI,0.69 至 0.86)和 1.00(95% CI,0.98 至 1.00)。纳入我们分析的研究似乎具有较低的方法学质量。Xpert Xpress 检测试剂盒对快速检测 SARS-CoV-2 具有出色的诊断准确性。然而,由于 ID NOW 检测试剂盒的敏感性相对较低,该检测方法可能会错过一些阳性样本。