Celltrion DiaTrust Point of Care (POC) COVID-19 Ag Rapid Test - 25 Tests Per Kit
POINT OF CARE USE ONLY - CLIA # or WAIVER REQUIRED
(By laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests)
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.
- 25 test devices
- 25 swabs
- 25 extraction buffer
- 25 filter caps
- 1 positive control swab
- 1 negative control swab
- 1 Quick Reference Instruction
- Sample type - NASOPHARYNGEAL SWAB SAMPLE (NPS)
- 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%
- Contents Images
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