Evaluation of 10 kits for antibody detection of SARS-CoV-2

ABSTRACT

Objective: To provide data reference for the clinical diagnosis of COVID-19, promote the innovation and improvement of antibody detection technology of COVID-19, and discuss the application of antibody detection of new coronavirus by evaluating the sensitivity, specificity, compliance rate and limit of antibody detection in 10 SARS-CoV-2 antibody detection kits. Methods: According to the instructions of 10 new coronavirus antibody detection kits, the specific IgM and IgG in 74 serum samples were detect- ed, and the limit of detection of each kit was tested with 10 samples diluted by a 2-fold gradient. Results: The coincidence rate of 10 kits(product A-product J)were 89.2%(66/74), 89.2%(66/74), 86.5%(64/74), 95.9%(71/74), 52.7%(39/74), 75.7%(56/74), 86.5%(64/74), 79.7%(59/74), 50.0%(37/74), 20.3%(15/74), respectively. In the detection limit tests for the kits A-J with the 10 of 2x gradient diluted samples, the performance of kit C was the best, with the limit of detection for IgM 0.16AU/ml and the limit of detection for IgG 1.00 AU/ml. Conclusion: There are significant differences in sensitivity, specificity, compliance and limit of detection of 10 new coronavirus antibody testing reagents, and the product of high sensitivity, specificity, and compliance rates should be selected for clinical applications to ensure the accuracy of test results.