Evaluation of two different domestic colloidal gold assay kit fornew coronavirus antibody in low endemic areas

ABSTRACT

This study aimed to evaluate the application and diagnostic efficacy of two different colloidal gold kits for the detection of 2019-nCoV immunoglobulin M antibody (anti-IgM) and immunoglobulin G antibody (anti-IgG) in Beijing, a low endemic area, and to guide the rational clinical application. The sera of 29 patients with confirmed novel coronavirus pneumonia (COVID-19) and 19 411 patients from the non-infected screening population were selected to evaluate the sensitivity, specificity and false-positive rate of the 2019-nCoV antibody test kits from Zhuhai Lizhu and Tangshan Innotek using colloidal gold immunochromatography. The sensitivity of Inotec 2019-nCoV was slightly higher than that of Lizhu 2019-nCoV, with a sensitivity of 58.62% and 55.17%, respectively;the specimen collection time of the all-negative group was significantly less than that of the antibody-positive group (P < 0.05);the false-positive rate of the two reagents in the low-prevalence area was 0.16%, and the false-positive rate of 2019-nCoV IgG was higher in Inotec than in Lizhu. The false positive rate for 2019-nCoV IgM was significantly higher than that for IgG for the same brand (Inotec ?2=14.756 09, P=0.000 0;Lizhu ?2=27.492 62, P=0.000). Conclusion The 2019-nCoV antibody test is rapid, simple and easy to perform, with high specificity, and can be used as a rapid screening indicator for new crowns;the specificity, correctness and negative predictive value of the two kits are good, and the application of the other kit for retesting when a positive result occurs can reduce the false positive rate of informing the clinic;the application and analysis of positive reports of new crown antibodies should be combined with the endemic area and clinical comprehensive judgment.