背景与目的2019年冠状病毒病(COVID-19)大流行给全球医疗保健系统带来了沉重负担。这凸显了对简单,快速,和负担得起的诊断测试,可以作为现有的昂贵和苛刻的聚合酶链反应(PCR)测定的替代品,特别是在加纳等资源有限的国家。鉴于此,我们的目的是评估三种COVID-19快速免疫层析抗原检测试剂盒与实时逆转录酶-PCR(rRT-PCR)。方法本研究评估了三种COVID-19快速免疫层析抗原检测试剂盒的敏感性和特异性:DGRapid,SDRapid,快速SS将它们与黄金标准RT-PCR进行比较,以检测75例随机选择的存档鼻咽样本中的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)核衣壳抗原。在测试的75个样本中,rRT-PCR检测SARS-CoV-2RNA阳性38例(50.7%),阴性37例(49.3%)。没有记录到假阳性。另一方面,DGRapid试剂盒检测到30例(78.9%)真阳性和8例(21.1%)假阴性。SDRapid试剂盒检测到28例(73.7%)真阳性和10例(26.3%)假阴性,而SSRapid试剂盒检测到19例(50.0%)真阳性和19例(50.0%)假阴性。虽然每个检测试剂盒的特异性为100%(95%CI),快速DG的灵敏度,SDRapid,SSRapid套件占79%,74%,和50%(95%CI),分别。对于每个试剂盒,在循环阈值(Ct)值<29.99的样品中记录到更高的灵敏度。此外,DGRapid试剂盒与rRT-PCR表现出79%的优异一致性,而SDRapid和SSRapid试剂盒与rRT-PCR表现出良好的一致性,分别为73%和50%的科恩kappa值,分别。结论根据我们的发现,DGRapid和SDRapid试剂盒是检测SARS-CoV-2感染的rRT-PCR的可靠替代品,特别是在加纳这样资源有限的环境中。
Background and objective The coronavirus disease 2019 (COVID-19) pandemic has imposed a significant burden on healthcare systems worldwide. This highlights the need for simple, rapid, and affordable diagnostic tests that can serve as alternatives to the existing costly and demanding polymerase chain reaction (PCR) assay, especially in resource-limited countries like Ghana. In light of this, we aimed to assess the diagnostic efficacy of three COVID-19 rapid immunochromatographic antigen test kits vs. real-time reverse transcriptase-PCR (rRT-PCR). Methods This study evaluated the sensitivity and specificity of three COVID-19 rapid immunochromatographic antigen test kits: DG Rapid, SD Rapid, and SS Rapid. They were compared with the gold standard RT-PCR for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antigen in 75 randomly selected archived nasopharyngeal samples. Results Of the 75 samples tested, 38 (50.7%) were positive and 37 (49.3%) were negative for SARS-CoV-2 RNA by rRT-PCR assay. No false positives were recorded. On the other hand, the DG Rapid kit detected 30 (78.9%) true positives and eight (21.1%) false negatives. SD Rapid kit detected 28 (73.7%) true positives and 10 (26.3%) false negatives, while the SS Rapid kit detected 19 (50.0%) true positives and 19 (50.0%) false negatives. While the specificity of each test kit was 100% (95% CI), the sensitivity of the DG Rapid, SD Rapid, and SS Rapid kits was 79%, 74%, and 50% (95% CI), respectively. Higher sensitivities were recorded among samples with cycle threshold (Ct) values <29.99 for each kit. Also, the DG Rapid kit demonstrated 79% excellent agreement with rRT-PCR, while the SD Rapid and SS Rapid kits demonstrated good agreement with rRT-PCR with 73% and 50% Cohen\'s kappa values, respectively. Conclusions Based on our findings, DG Rapid and SD Rapid kits are reliable alternatives to rRT-PCR for the detection of SARS-CoV-2 infection, especially in resource-limited settings like Ghana.