Establishment Of Immunological Detection Method For Novel Coronavirus SARS-CoV-2

Since the outbreak of Corona Virus Disease 2019,human life and property have been greatly damaged.Experts estimate that New Coronavirus may coexist with humans for a long time.Therefore,early diagnosis and early treatment techniques and products have become the focus of attention in clinical medicine,life sciences and pharmacy.Based on the commercial SARS-Co V-2 antigen and antibody,and using immunological principle as the basis of detection,three methods of Serology Detection for New Coronavirus were established.They are colloidal gold immunochromatography assay,enzyme-linked immunosorbent assay and magnetic bead chemiluminescence immunoassay.The experimental conditions of the three methods are optimized and three kinds of methods are studied.The linear correlation range,specificity,sensitivity and intra assay repeatability of the method were analyzed.The results showed that the colloidal gold immunoassay method could detect at least 12ng/ml Ig M and Ig G antibodies,the coefficient of variation within the same batch and between different batches was less than 5%,there was no cross reaction with other interfering substances,the clinical application performance evaluation met the standard,and achieved good qualitative detection.The linear regression equation was y=0.3163x+0.8556,and the correlation coefficient was R~2=0.996.The lowest detectable antigen was 0.25ng/ml,and there was no cross reaction with other proteins.The recovery rate was 99.25%,and the coefficient of variation was less than 10%,which met the requirements and had clinical application value.The linear concentration was 0.25-16ng/ml,the linear regression equation was y=331.72+11725,the correlation coefficient was 0.9961,the lowest detectable antigen concentration was 0.125ng/ml,there was no cross reaction with interfering substances,the coefficient of variation was less than 10%,the recovery rate was more than 99%,there was no false negative"HOOK"phenomenon.This study provides a laboratory basis for clinical rapid detection.