Chunyan Zhang1, Lei Zhou2,3, Kang Du4, Ying Zhang5, Jing Wang6, Lijuan Chen7, Yanning Lyu7, Jun Li5, Hao Liu2,3, Junli Huo8,9, Fei Li8,9, Jiayi Wang10,11, Peipei Sang1, Si Lin12, Yi Xiao12, Kan Zhang10,11, Kunlun He13. 1. Birth Defects Prevention and Control Technology Research Center, Chinese PLA General Hospital, Beijing, China. 2. Clinical Laboratory, Wuhan Huoshenshan Hospital, Wuhan, China. 3. Clinical Laboratory, Xijing Hospital of Air Force Medical University of PLA, Xi'an, China. 4. School of Precision Instruments and Optoelectronics Engineering, Tianjin University, Tianjin, China. 5. Clinical Laboratory, First Medical Center of Chinese PLA General Hospital, Beijing, China. 6. Clinical Laboratory, Chongqing Public Health Medical Center, Southwest University Public Health Hospital, Chongqing, China. 7. Institute of Infectious and Endemic Diseases Prevention and Control, Beijing Center for Diseases Prevention and Control, Beijing, China. 8. Infections Department, Wuhan Huoshenshan Hospital, Wuhan, China. 9. Neurosurgery Department, Xijing Hospital of Air Force Medical University of PLA, Xi'an, China. 10. Medical Department, Wuhan Huoshenshan Hospital, Wuhan, China. 11. Cardiovascular Medicine Department, Xijing Hospital of Air Force Medical University of PLA, Xi'an, China. 12. Beijing Savant Biotechnology Co., Ltd., Beijing, China. 13. Translational Medicine Research Center, Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine, Chinese PLA General Hospital, Beijing, China.
Abstract
Purpose: To develop a rapid detection reagent for SARS-CoV-2 antigen for the auxiliary diagnosis of new coronary pneumonia (COVID-19), and perform the methodological evaluation and clinical evaluation of the reagent. Method: SARS-CoV-2 N-protein test strip was created by combining fluorescent microsphere labeling technology and immunochromatographic technology, based on the principle of double antibody sandwich. Then we evaluated the analytical capability and clinical application of the strips. Result: The limit of detection of the strips for recombinant N protein was 100 ng/ml and for activated SARS -CoV-2 virus was 1 × 103 TCID50/ml. The strips also have high analytical specificity and anti-interference capability. According to the predetermined cut-off value, the specificity of the test strip in healthy controls and patients with other respiratory disease was 100.00 and 97.29%, the sensitivity in COVID-19 cases at progress stage and cured stage was 67.15 and 7.02%. The positive percentage agreement and negative percentage agreement of antigen strip to RNA test were 83.16 and 94.45%. Conclusion: SARS-CoV-2 fluorescence immunochromatographic test strip can achieve fast, sensitive and accurate detection, which can meet the clinical requirements for rapid detection of viruses on the spot.
Purpose: To develop a rapid detection reagent for SARS-CoV-2 antigen for the auxiliary diagnosis of new coronary pneumonia (COVID-19), and perform the methodological evaluation and clinical evaluation of the reagent. Method: SARS-CoV-2 N-protein test strip was created by combining fluorescent microsphere labeling technology and immunochromatographic technology, based on the principle of double antibody sandwich. Then weevaluated the analytical capability and clinical application of the strips. Result: The limit of detection of the strips for recombinant N protein was 100 ng/ml and for activated SARS -CoV-2 virus was 1 × 103 TCID50/ml. The strips also have high analytical specificity and anti-interference capability. According to the predetermined cut-off value, the specificity of the test strip in healthy controls and patients with other respiratory disease was 100.00 and 97.29%, the sensitivity in COVID-19 cases at progress stage and cured stage was 67.15 and 7.02%. The positive percentage agreement and negative percentage agreement of antigen strip to RNA test were 83.16 and 94.45%. Conclusion:SARS-CoV-2 fluorescence immunochromatographic test strip can achieve fast, sensitive and accurate detection, which can meet the clinical requirements for rapid detection of viruses on the spot.
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