FDA Emergency Use Authorized In Vitro Diagnostic COVID-19 Test Kit by Celltrion.
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.
Celltrion DiaTrust™ COVID-19 Ag Rapid Test / 25 per box
Product Details
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
Specifications
Sample type: NASOPHARYNGEAL SWAB SAMPLE (NPS)
Storage temperature: 2 - 30°C (36 - 86°F)
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%Do not use the test device beyond the expiration date.
Contents includes 25 complete test kits:
- 25 Test Devices
- 25 Swabs
- 25 Extraction Buffers
- 25 Filter Caps
- 1 Positive Control Swab
- 1 Negative Control Swab
- 1 Quick Reference Instruction