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10.1016/j.ijid.2020.05.098

http://scihub22266oqcxt.onion/10.1016/j.ijid.2020.05.098
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32497809!7263236!32497809
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suck abstract from ncbi


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pmid32497809      Int+J+Infect+Dis 2020 ; 99 (ä): 328-333
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  • Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples #MMPMID32497809
  • Porte L; Legarraga P; Vollrath V; Aguilera X; Munita JM; Araos R; Pizarro G; Vial P; Iruretagoyena M; Dittrich S; Weitzel T
  • Int J Infect Dis 2020[Oct]; 99 (ä): 328-333 PMID32497809show ga
  • OBJECTIVES: In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. METHODS: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. RESULTS: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5-97.4%) and 100% (95% confidence interval 92.1-100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. CONCLUSIONS: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Betacoronavirus/genetics/*immunology[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |COVID-19 Vaccines[MESH]
  • |Child[MESH]
  • |Child, Preschool[MESH]
  • |Clinical Laboratory Techniques/*methods[MESH]
  • |Coronavirus Infections/*diagnosis/virology[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Infant[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Nasopharynx/virology[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis/virology[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Viral Load[MESH]


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