Department of Laboratory Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Department of Medical Laboratory Sciences and Biotechnology, Fooyin University, Kaohsiung, Taiwan.
Division of Chest Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Biomed J. 2021 Mar;44(1):101-104. doi: 10.1016/j.bj.2020.12.007. Epub 2020 Dec 29.
The current coronavirus disease 2019 (COVID-19) pandemic has caused significant challenges throughout the world and a rapid, reliable diagnostic test is in high demand. Real-time reverse transcription polymerase chain reaction (RT-PCR) was one of the most quickly established methods of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection and is considered to be the gold standard. In this report, we share our experience of using two different testing platforms: the cobas 6800 SARS-CoV-2 test, an automated system that was recently granted Emergency Use Authorization by the FDA, and a laboratory-developed test based on the protocol from the Taiwan Centers for Disease Control (CDC). There was an overall 96.2% agreement between the two platforms. However, the positive agreement between the two platforms was only 80.0%. We found 3 instances of discordance between the two systems and this emphasized the need for timely diagnosis with a reliable testing platform.
当前的 2019 年冠状病毒病（COVID-19）大流行在全球范围内造成了重大挑战，因此对快速、可靠的诊断测试的需求很高。实时逆转录聚合酶链反应（RT-PCR）是最快速建立的严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）检测方法之一，被认为是金标准。在本报告中，我们分享了使用两种不同测试平台的经验：cobas 6800 SARS-CoV-2 测试，这是一种最近获得美国食品和药物管理局（FDA）紧急使用授权的自动化系统，以及基于台湾疾病管制署（CDC）方案开发的实验室检测。这两个平台之间的总体一致性为 96.2%。然而，两个平台之间的阳性一致性仅为 80.0%。我们发现两个系统之间存在 3 例不一致的情况，这强调了需要及时使用可靠的测试平台进行诊断。
