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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.
Product Specifications
Sample type: NASOPHARYNGEAL SWAB SAMPLE (NPS)
Storage Temperature: 2 - 30°C (36 - 86°F)
Sample-to-answer time: 15 mins
CLINICAL PERFORMANCE
All subjects:
Positive Percentage Agreement: 86.7 % (95% CI: 73.8%-93.7%)
Negative Percentage Agreement: 99.8 % (95% CI: 98.7%-100.0%)
Symptomatic subjects:
Positive Percentage Agreement: 86.1% (95% CI: 71.3% - 93.9%)
Negative Percentage Agreement: 99.4% (95% CI: 96.8% - 99.9%)
Asymptomatic subjects:
Positive Percentage Agreement: 88.9 % (95% CI: 56.8%-98.0%)
Negative Percentage Agreement: 100.0% (95% CI: 98.6%-100.0%)
2-Kit Package contains:
POC Test Device Package
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