Your browser doesn't support javascript.
loading
[International multi-center evaluation of a rapid antigen test based on gold immunochromatographic assay for detection of severe acute respiratory syndrome coronavirus 2].
Zhang, P P; Zhang, J; Sun, Z L; Zhou, Y G; Wang, Y; Zhang, H R; Xiao, R F; Li, Y Z; Mu, R; Zhao, Y; Song, Y J; Yang, R F; Lin, Changqing.
Afiliação
  • Zhang PP; Beijing Key Laboratory of POCT for Bioemergency and Clinic (BZ0329), Beijing 100071, China.
  • Zhang J; Beijing Key Laboratory of POCT for Bioemergency and Clinic (BZ0329), Beijing 100071, China.
  • Sun ZL; College of Veterinary Medicine, South China Agricultural University, Guangzhou 510630, China.
  • Zhou YG; School of Basic Medical Sciences, Guizhou Medical University, Guiyang 550025, China.
  • Wang Y; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Zhang HR; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Xiao RF; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Li YZ; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Mu R; School of Basic Medical Sciences, Guizhou Medical University, Guiyang 550025, China.
  • Zhao Y; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Song YJ; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Yang RF; Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071, China.
  • Lin C; Beijing Key Laboratory of POCT for Bioemergency and Clinic (BZ0329), Beijing 100071, China.
Zhonghua Yi Xue Za Zhi ; 102: 1-6, 2022 Jun 13.
Article em Zh | MEDLINE | ID: mdl-35701088
Objective: The gold immunochromatographic assay for detection of SARS-CoV-2 antigen was evaluated by international multi-center clinical trial. Methods: A total of 1 855 clinical parallel samples with valid test results (for nucleic acid and antigen tests, respectively) were collected from nine countries, including Germany, the United Kingdom, Ukraine, France, India, Thailand, Malaysia, the United States of America and Brazil, with sampling period from January 3, 2021 to September 22, 2021. These samples were detected by SARS-CoV-2 antigen test kit (colloidal gold immunochromatography assay) and nucleic acid detection kit (real-time fluorescent quantitative reverse transcription polymerase chain reaction). Positive coincidence rates [(number of antigen-positive cases/nucleic acid-positive cases)×100%], negative coincidence rates [(number of antigen-negative cases/nucleic acid-negative cases)×100%], total coincidence rates [(number of cases with consistent results for both antigen and nucleic acid detection/number of total cases) ×100%], as well as Kappa values were calculated. The differences of the above indictors among different countries were evaluated by the coefficient of variation. The detection rates of the antigen test for samples with different cycle threshold values (Ct values) for the nucleic acid detection, different characteristics and different mutant strains were analyzed. Results: For all samples, the positive, negative, and total coincidence rate between the antigen test and nucleic acid assay was 90.8% (569/627), 99.7% (1 224/1 228) and 96.7% (1 793/1 855), respectively, and the consistency coefficient Kappa value was 0.924. Among these countries, the coefficient of variation for positive coincidence rates (except for Malaysia with a lot of samples with Ct value>30), negative coincidence rates (except for France without negative samples) and total coincidence rates (except for France) was 6%,<1%, and 6%, respectively. When Ct values were less than 25, the detection rates of antigen test were 83.3%-100% for each countries (the coefficient of variation was 6%); The total detection rate and the coefficient of variation was 93.4% (428/458) and 5%, respectively, for asymptomatic infected persons and cases within 7 days post onset of symptoms; the total detection rate for various SARS-CoV-2 mutant strains was 97.5% (119/122); and it showed negative results for samples from cases infected with other viruses, including influenza A virus subtype H1N1, influenza B virus, respiratory syncytial virus subgroups A and B, coxsackievirus 16, human metapneumovirus, parainfluenza virus types 1 and 4, Epstein-Barr virus and adenovirus. Conclusion: The SARS-CoV-2 antigen test kit showed excellent authenticity, and there were few differences for its indictors among nine countries, therefore it can meet the needs of large-scale early screening of SARS-CoV-2 infection.

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies Idioma: Zh Revista: Zhonghua Yi Xue Za Zhi Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies Idioma: Zh Revista: Zhonghua Yi Xue Za Zhi Ano de publicação: 2022 Tipo de documento: Article