Medical Technology School of Xuzhou Medical University, Xuzhou Key Laboratory of Laboratory Diagnostics, Xuzhou 221004, China.
Nanjing Vazyme Medical Technology Co. Ltd., Nanjing 210046, China.
Clin Chim Acta. 2020 Nov;510:35-46. doi: 10.1016/j.cca.2020.06.045. Epub 2020 Jul 2.
The outbreak of Coronavirus Disease-2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has threatened health worldwide. As of the end of 2020, there were nearly 10 million confirmed cases and nearly 5 million deaths associated with COVID-19. Rapid and early laboratory diagnosis of COVID-19 is the main focus of treatment and control. Molecular tests are the basis for confirmation of COVID-19, but serological tests for SARS-CoV-2 are widely available and play an increasingly important role in understanding the epidemiology of the virus and in identifying populations at higher risk for infection. Point-of-care tests have the advantage of rapid, accurate, portable, low cost and non-specific device requirements, which provide great help for disease diagnosis and detection. This review will discuss the performance of different laboratory diagnostic tests and platforms, as well as suitable clinical samples for testing, and related biosafety protection. This review shall guide for the diagnosis of COVID-19 caused by SARS-CoV-2.
由严重急性呼吸系统综合征冠状病毒 2 型（SARS-CoV-2）引起的 2019 年冠状病毒病（COVID-19）疫情已在全球范围内威胁到人类健康。截至 2020 年底，与 COVID-19 相关的确诊病例接近 1000 万例，死亡病例接近 500 万例。COVID-19 的快速和早期实验室诊断是治疗和控制的主要重点。分子检测是 COVID-19 确诊的基础，但 SARS-CoV-2 的血清学检测已广泛应用，并在了解病毒的流行病学和识别具有更高感染风险的人群方面发挥着越来越重要的作用。即时检测具有快速、准确、便携、低成本和非特定设备要求的优势，为疾病诊断和检测提供了极大的帮助。本综述将讨论不同实验室诊断检测和平台的性能，以及适合检测的临床样本，以及相关的生物安全防护。本综述将为 SARS-CoV-2 引起的 COVID-19 的诊断提供指导。
