背景:逆转录酶聚合酶链反应(RT-PCR)是确认SARS-CoV-2感染病例的参考诊断方法。然而,已经开发了各种抗原快速诊断测试(Ag-RDTs)。这项荟萃分析研究的目的是评估Panbio™Ag-RDT(AbbottPointofCare)在鉴定SARS-CoV-2病毒中的诊断性能。
方法:从2020年3月到2023年3月,我们系统地搜索了八个数据库,以寻找可能符合条件的文章。Panbio™Ag-RDT的诊断荟萃分析使用了多种评价指标,包括灵敏度,特异性,诊断赔率比(DOR),和曲线下面积(AUC)值。
结果:在确定的794篇文章中,49项研究符合纳入标准。用于诊断SARS-CoV-2的Panbio™Ag-RDT的汇总估计为0,65(95%CI:0,64-0,66),0,99(95%CI:0,99-1,00),578,03(95%CI:333,37-1002,26)用于灵敏度,特异性,和DOR,分别。此外,摘要接受者工作特征(SROC)曲线显示AUC值为0.942(95%CI:0.941-0.943),这表明了出色的诊断准确性。亚组和荟萃回归分析显示,学习期间,年龄,研究人群和周期阈值(Ct)值构成了异质性的来源。此外,我们证明了使用Deek检验(p=0,001)和漏斗图分析的DOR值的发表偏倚。
结论:Panbio™Ag-RDT在有或无症状的成人和儿童中检测SARS-CoV-2病毒方面具有出色的诊断准确性。
The reverse transcriptase polymerase chain reaction (RT-PCR) is the reference diagnostic method for the confirmation of SARS-CoV-2 infected cases. However, various antigen rapid diagnostic tests (Ag-RDTs) have been developed. The purpose of this meta-analysis study was to assess the diagnostic performance of Panbio™ Ag-RDT (Abbott Point of Care) in identifying the SARS-CoV-2 virus.
We systematically searched eight databases from March 2020 until March 2023 to look for potentially eligible articles. Diagnostic meta-analysis of Panbio™ Ag-RDT used diverse evaluation indicators, including sensitivity, specificity, Diagnostic Odds Ratio (DOR), and the area under the curve (AUC) value.
Of the 794 articles identified, 49 studies met the inclusion criteria. The pooled estimates of Panbio™ Ag-RDT for the diagnosis of SARS-CoV-2 were 0,65 (95% CI: 0,64-0,66), 0,99 (95% CI: 0,99-1,00), 578,03 (95% CI: 333,37-1002,26) for sensitivity, specificity, and DOR, respectively. Moreover, the summary receiver operating characteristic (SROC) curve revealed an AUC value of 0,942 (95% CI: 0,941-0,943), suggesting an outstanding diagnostic accuracy. Subgroup and meta-regression analyses showed that continent, study period, age, study population and cycle threshold (Ct) values constituted a source of heterogeneity. Furthermore, we demonstrated proof of publication bias for DOR values analyzed using Deek\'s test (p = 0,001) and funnel plot.
Panbio™ Ag-RDT presented an outstanding diagnostic accuracy in the detection of the SARS-CoV-2 virus in both adults and children with or without symptoms.