Abstract:

Corona virus disease 2019（COVID-19） epidemic has seriously endangered human health and economic and social development. Accurate etiological determination in clinical laboratories is a prerequisite for epidemic prevention and control. At present,clinical laboratory determination technologies for severe acute respiratory syndrome coronavirus-2 mainly include nucleic acid,antibody and antigen determinations. Nucleic acid determination is a gold standard for the COVID-19 diagnosis with high sensitivity and specificity,but it has high requirements for personnel technical needs and experimental conditions. Antibody determination can be used as a supplement for nucleic acid determination to reduce missed determination and monitor the disease progress,while universal vaccination will affect the interpretation of antibody determination results,like false positivity. Antigen determination is convenient and fast,which can be operated at home,but its sensitivity is greatly affected by the disease process and viral load. In order to improve the efficiency of large-scale population screening,the National Health Commission has successively issued 5-in-1,10-in-1,and 20-in-1 mixed sampling technologies. However,the multiplication of preservation solution in the mixed sampling tube will result in virus dilution and increase the missed determination probability,and mixed sampling also aggravates the workload of epidemiological investigation and subsequent confirmation of the positive specimen in primary screening. With the progress of the COVID-19 epidemic,the SARS-CoV-2 continues to mutate,and the clinical laboratory determination technologies are gradually enriched and improved. Accurate analysis and judgment of the advantages and disadvantages of existing determination technologies and their application scenarios are conducive to the scientific prevention and control of the epidemic. This review will analyzes the following key clinical laboratory determination technical issues and put forward application suggestions,including the “mixed sampling” and “mixed determination” in nucleic acid determination,the impact of virus mutation on the performance of nucleic acid determination,the advantages and disadvantages of “endogenous” and “exogenous” internal standards in nucleic acid determination,the clinical significance and application scenarios of antigen determination and the value of antibody determination after vaccination.

Key words: Severe acute respiratory syndrome coronavirus-2, Clinical laboratory determination, Virus mutation, Analytical performance