Biogenix Lab G42, Abu Dhabi, UAE.
G42 Healthcare, Abu Dhabi, UAE.
J Med Virol. 2021 Sep;93(9):5538-5543. doi: 10.1002/jmv.27090. Epub 2021 Jun 8.
In the current coronavirus disease 2019 (COVID-19) pandemic there is a mass screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) happening around the world due to the extensive spread of the infections. There is a high demand for rapid diagnostic tests to expedite the identification of cases and to facilitate early isolation and control spread. Hence this study evaluates six different rapid nucleic acid detection assays that are commercially available for SARS-CoV-2 virus detection. Nasopharyngeal samples were collected from 4981 participants and were tested for the SARS-CoV-2 virus by the gold standard real-time reverse-transcription polymerase chain reaction (RT-PCR) method and with one of these six rapid methods of detection. Evaluation of the rapid nucleic acid detection assays was done by comparing the results of these rapid methods with the gold standard RT-qPCR results for SARS-COV-2 detection. AQ-TOP had the highest sensitivity (98%) and a strong kappa value of 0.943 followed by Genechecker and Abbot ID NOW. The POCKIT (ii RT-PCR) assay had the highest test accuracy of 99.29% followed by Genechecker and Cobas Liat. Atila iAMP showed the highest percentage of invalid reports (35.5%) followed by AQ-TOP with 6% and POCKIT with 3.7% of invalid reports. Genechecker system, Abbott ID NOW, and Cobas Liat were found to have the best performance and agreement when compared with the standard RT-PCR for COVID-19 detection. With further research, these rapid tests have the potential to be employed in large-scale screening of COVID-19.
在当前的 2019 年冠状病毒病(COVID-19)大流行中,由于感染的广泛传播,全世界正在进行大规模的严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)筛查。对于快速诊断测试的需求很高,以便加快确定病例,并便于早期隔离和控制传播。因此,本研究评估了六种可商购的用于 SARS-CoV-2 病毒检测的快速核酸检测试剂盒。从 4981 名参与者中采集鼻咽样本,并通过金标准实时逆转录聚合酶链反应(RT-PCR)方法和这六种快速检测方法之一对 SARS-CoV-2 病毒进行检测。通过将这些快速方法的结果与 SARS-COV-2 检测的金标准 RT-qPCR 结果进行比较,对快速核酸检测试剂盒进行评估。AQ-TOP 的灵敏度最高(98%),kappa 值为 0.943,紧随其后的是 Genechecker 和 Abbot ID NOW。POCKET(ii RT-PCR)检测试剂盒的测试准确性最高,为 99.29%,其次是 Genechecker 和 Cobas Liat。Atila iAMP 报告无效的比例最高(35.5%),其次是 AQ-TOP(6%)和 POCKET(3.7%)。与标准 RT-PCR 相比,Genechecker 系统、 Abbott ID NOW 和 Cobas Liat 在检测 COVID-19 时被发现具有最佳的性能和一致性。随着进一步的研究,这些快速检测方法有可能在大规模 COVID-19 筛查中得到应用。