National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.
Peking University Fifth School of Clinical Medicine, Beijing Hospital, Beijing, P. R. China.
Clin Chem. 2020 Aug 1;66(8):1030-1046. doi: 10.1093/clinchem/hvaa122.
The ongoing outbreak of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed a challenge for worldwide public health. A reliable laboratory assay is essential both to confirm suspected patients and to exclude patients infected with other respiratory viruses, thereby facilitating the control of global outbreak scenarios.
In this review, we focus on the genomic, transmission, and clinical characteristics of SARS-CoV-2, and comprehensively summarize the principles and related details of assays for SARS-CoV-2. We also explore the quality assurance measures for these assays.
SARS-CoV-2 has some unique gene sequences and specific transmission and clinical features that can inform the conduct of molecular and serological assays in many aspects, including the design of primers, the selection of specimens, and testing strategies at different disease stages. Appropriate quality assurance measures for molecular and serological assays are needed to maintain testing proficiency. Because serological assays have the potential to identify later stages of the infection and to confirm highly suspected cases with negative molecular assay results, a combination of these two assays is needed to achieve a reliable capacity to detect SARS-CoV-2.
新型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的持续爆发对全球公共卫生构成了挑战。可靠的实验室检测对于确诊疑似患者和排除感染其他呼吸道病毒的患者至关重要，从而有助于控制全球疫情爆发。
本文重点关注 SARS-CoV-2 的基因组、传播和临床特征，并全面总结了 SARS-CoV-2 检测的原理和相关细节，同时还探讨了这些检测的质量保证措施。
SARS-CoV-2 具有一些独特的基因序列和特定的传播和临床特征，这在分子和血清学检测的设计方面具有指导意义，包括引物设计、标本选择以及不同疾病阶段的检测策略。需要采取适当的分子和血清学检测的质量保证措施来保持检测的准确性。由于血清学检测有可能识别感染的后期阶段，并确认分子检测结果为阴性的高度疑似病例，因此需要将这两种检测方法结合起来，以实现对 SARS-CoV-2 的可靠检测能力。
