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.
ABSTRACT
Objective: To compare and analyze 7 new coronavirus nucleic acid detection kits and 5 nucleic acid extraction methods. Methods: After extracting nucleic acids from 44 positive coronavirus clinical samples, 7 SARS-CoV-2 nucleic acid detection kits were used for RT-PCR amplification experiments to compare the positive rate and Ct value;33 new coronavirus positive clinical samples were selected to compare the acid extraction methods. Five different nucleic acid extraction methods were used to extract the samples, and then RT-PCR amplification experiments were performed to compare the positive rate and Ct value. Results: The brand A nucleic acid extraction kit had the highest positive rate and the lowest rate of missed detection;comparison of nucleic acid extraction methods showed that the manual column extraction method had the highest positive rate, followed by the magnetic bead extraction method, and the one-step extraction method had the highest missed detection rate. Conclusion: The detection capabilities of the SARS-CoV-2 detection kits are uneven, so evaluation work needs to be done before the selection of the kit. The manual column extraction method showed best extraction efficiency but took a long time. Because of the possible combination with the automatic nucleic acid extraction instrument, the magnetic bead extraction method had a high extraction efficacy, which might be suitable for use in the ex- traction of large batches of samples. Although the one-step extraction method was easily operable, the method had a high missed detection rate, so this method was not recommended for clinical use.