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10.3390/v13050796

http://scihub22266oqcxt.onion/10.3390/v13050796
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33946860!8146967!33946860
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suck abstract from ncbi


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pmid33946860      Viruses 2021 ; 13 (5): ä
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  • Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody COVAG025) for COVID-19 Diagnosis #MMPMID33946860
  • Kim D; Lee J; Bal J; Seo SK; Chong CK; Lee JH; Park H
  • Viruses 2021[Apr]; 13 (5): ä PMID33946860show ga
  • Antigen tests for SARS-CoV-2 diagnosis are simpler and faster than their molecular counterparts. Clinical validation of such tests is a prerequisite before their field applications. We developed and clinically evaluated an immunochromatographic immunoassay, GenBody COVAG025, for the rapid detection of SARS-CoV-2 nucleocapsid (NP) antigen in two different clinical studies. Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody COVAG025, revealed a sensitivity and specificity of 90.00% (27/30; 95% CI: 73.47% to 97.89%) and 98.00% (98/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. Subsequently, the prospective examination of 200 symptomatic and asymptomatic nasopharyngeal swabs, collected on site and tested with GenBody COVAG025 and EUA-approved real-time RT-PCR assay simultaneously, revealed a significantly higher sensitivity and specificity of 94.00% (94/100; 95% CI: 87.40% to 97.77%) and 100.00% (100/100; 95% CI: 96.38% to 100.00%), respectively. Clinical sensitivity and specificity were significantly high for samples with Ct values
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Coronavirus Nucleocapsid Proteins/*immunology[MESH]
  • |Diagnostic Tests, Routine[MESH]
  • |Enzyme-Linked Immunosorbent Assay/*methods[MESH]
  • |Humans[MESH]
  • |India/epidemiology[MESH]
  • |Nasopharynx/*virology[MESH]
  • |Phosphoproteins/immunology[MESH]
  • |Prospective Studies[MESH]
  • |Republic of Korea/epidemiology[MESH]
  • |Retrospective Studies[MESH]
  • |SARS-CoV-2/*isolation & purification[MESH]


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