Celltrion DiaTrust COVID-19 Ag Test

Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.

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Description

Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.

  • Sample type: Nasopharyngeal Swab Sample
  • Storage temperature: 2-30°C (36-86°F)
  • Sample-to-answer time: 15 mins
  • Prospective Study
    • Clinical sensitivity: 93.33% (28/30) (95% CI: 78.7%-98.2%)
    • Clinical specificity: 99.03% (102/103) (95% CI: 94.7%-99.8%)
    • Positive predictive value: 96.55% (28/29) (95% CI: 82.8%-99.4%)
    • Negative predictive value: 98.08% (102/104) (95% CI: 93.3%-99.5%)
    • Prevalence: 22.56%