Intended Use
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.
PRESCRIPTION USE (POC)
Rapid results in 15 min
93.33% Sensitivity and 99.03% Specificity
By laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests
Lateral Flow Immunoassay
Read results at 15 mins
Nasopharyngeal Swab (NPS)
FOR USE UNDER THE EMERGENCY USE AUTHORIZATION (EUA) ONLY
93.33%
(95% CI: 78.7%-98.2%)
99.03%
(95% CI: 94.7%-99.8%)
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