Molecular and Serological Assays for SARS-CoV-2: Insights From Genome and Clinical Characteristics

Clin Chem. 2020 May 21;hvaa122. doi: 10.1093/clinchem/hvaa122. Online ahead of print.


Background: 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.

Content: 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.

Summary: 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.

Keywords: SARS-CoV-2; application; molecular assays; quality assurance; serological assays.