JIANG Xiaolu, DU Mingqiu, YANG Lancui, FAN Chenxia, ZHENG Ming. Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance[J]. Chinese Journal of Medical Instrumentation, 2023, 47(1): 99-105. DOI: 10.3969/j.issn.1671-7104.2023.01.018
      Citation: JIANG Xiaolu, DU Mingqiu, YANG Lancui, FAN Chenxia, ZHENG Ming. Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance[J]. Chinese Journal of Medical Instrumentation, 2023, 47(1): 99-105. DOI: 10.3969/j.issn.1671-7104.2023.01.018

      Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance

      • Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.
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