Celltrion Diatrust COVID-19 Rapid Antigen Test (POC)

Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen

This is an FDA EUA 15 Minute Rapid Antigen Test created for the qualitative detection of COVID-19 antigen. It is intended to aid in the rapid diagnosis of COVID-19 infections.
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.

FDA EUA

Yes!

Results

15 minutes

Type

Nasopharyngeal, anterior nasal
Lateral flow assay

Positive Predictive Value

96.55%

Negative Predictive Value

98.08%

Application

Point of care (POC)

Tests per Kit

25 tests per box

Shelf Life

12 Months

Sensitivity

93.3%

Specificity

99.03%

Availability

Immediate

FDA EUA

Authorization Letter

Brochure

Fact Sheet

For HealthCare Providers

Quick Reference

Instruction

FDA Disclaimer

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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