Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance.
10.3969/j.issn.1671-7104.2023.01.018
- Author:
Xiaolu JIANG
1
;
Mingqiu DU
2
;
Lancui YANG
2
;
Chenxia FAN
2
;
Ming ZHENG
2
Author Information
1. Zhejiang Institute of Medical Device Testing, Hangzhou,
2. Hangzhou Singclean Medical Products Co. Ltd., Hangzhou,
- Publication Type:Journal Article
- Keywords:
SARS-CoV-2;
analytical performance evaluation;
coronavirus infection;
in vitro diagnostics
- MeSH:
Humans;
COVID-19;
COVID-19 Testing;
Sensitivity and Specificity;
SARS-CoV-2
- From:
Chinese Journal of Medical Instrumentation
2023;47(1):99-105
- CountryChina
- Language:Chinese
-
Abstract:
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.
