Medical Virology, University of Pretoria, Pretoria, South Africa
Zoonotic Arbo- and Respiratory Virus Research Program, Centre for Viral Zoonosis, University of Pretoria, Pretoria, South Africa.
J Clin Pathol. 2020 Jul;73(7):370-377. doi: 10.1136/jclinpath-2020-206685. Epub 2020 May 13.
Countries globally are affected by the COVID-19 pandemic, with nearly two million cases and 120 000 deaths occurring within 4 months of the discovery of the severe acute respiratory syndrome coronavirus-2 in December 2019 in China. Accurate diagnoses of cases is key in managing the pandemic by identification, isolation and treatment of patients and defining the epidemiology of the virus. By mid-January 2020, a scientist from China published the full genome of the virus, which facilitated the development of accurate molecular diagnostic assays. By the end of January 2020, the WHO, in collaboration with laboratories in Asia, Europe and the USA, published several real-time reverse transcriptase PCR (rtRT-PCR) protocols that allowed identification of cases and development of commercial assays. Clinical investigations facilitated development of accurate case definition and guidance for laboratories on the optimum specimens and procedures for diagnoses. Currently, laboratory-based rtRT-PCR is the recommended test for diagnoses of acute cases to ensure patients can be identified and isolated and to facilitate the public health response. However, due to delays in diagnoses, severe shortage of tests and laboratory capacity, point-of-care molecular or antigen tests are becoming more attractive. Although serological tests are not suitable for diagnoses of acute cases, they are important to define epidemiological questions, including attack rate in the population, and to identify immune individuals. This review aimed to summarise the current available information for diagnoses of cases and to aid laboratories and healthcare workers to select the best assays and procedures.
全球各国都受到了 COVID-19 大流行的影响，自 2019 年 12 月在中国发现严重急性呼吸综合征冠状病毒 2 以来的 4 个月内，已发生近 200 万例病例和 120000 例死亡。通过识别、隔离和治疗患者以及确定病毒的流行病学来准确诊断病例是管理大流行的关键。到 2020 年 1 月中旬，一位中国科学家发表了该病毒的全基因组，这促进了准确的分子诊断检测方法的开发。到 2020 年 1 月底，世界卫生组织与亚洲、欧洲和美国的实验室合作，发布了几个实时逆转录聚合酶链反应（rtRT-PCR）方案，这些方案允许识别病例和开发商业检测方法。临床研究促进了准确病例定义的发展，并为实验室提供了有关最佳标本和诊断程序的指导。目前，基于实验室的 rtRT-PCR 是诊断急性病例的推荐检测方法，以确保能够识别和隔离患者，并促进公共卫生应对。然而，由于诊断的延迟、检测和实验室能力的严重短缺，即时护理点分子或抗原检测变得更具吸引力。尽管血清学检测不适合诊断急性病例，但它们对于确定流行病学问题（包括人群中的发病率）和识别免疫个体非常重要。本文综述了目前可用于诊断病例的信息，以帮助实验室和医疗保健工作者选择最佳的检测方法和程序。
