Protocol for the clinical performance assessment of SARS - CoV - 2 antibody testing reagent

ABSTRACT

To date, the coronavirus disease 2019 (COVID-19) pandemic is impacting globally. COVID-19 is mainly diagnosed via viral nucleic acid testing, but with the disadvantages of unsatisfactory sensitivity and high requirements for expensive equipment and facility the operating settings. Compared with nucleic acid testing, antibody testing usually has advantages as wide popularization, convenient sample collection, easy to achieve high throughput. less workload, high reproducibility, and low cost, therefore it will be an efficient supplement for nucleic acid detection to confirm COVID-19. This protocol provided detailed design for the assessment of antibody testing reagent, including consideration for the study objectives, calculation of sample size, inclusion and exclusion criteria, blinding method, experimental specimen, ethical issues, study management and quality control, data management and statistical analysis. and results report and so on, aiming to assist the researchers to systematically assess the critical performance of antibody testing reagent prior to large-scale application of the antibody testing reagent, so that researchers could make reasonable choices among different antibody testing reagents according to their respective purposes.