The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within five days of symptom onset.
Product Non-Refundable, Non-Returnable
For Medical Professionals
Not for consumer or at home use
CLIA Waived Number to Purchase Required
The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a lateral flow immunochromatographic assay that has been authorized only for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers, not for any other viruses or pathogens.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Antigen Test Kit (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
As an intended Point-of-Care (POC) designated test with a 10 minute read processing time.
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
Read the result at 10 minutes. The test result should not be read after 15 minutes
Warning: The false positive, false negative, or invalid results may occur if the test is interpreted outside of the interpretation window.
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; and, 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Fact Sheet for Healthcare Providers
Instructions for Use
Fact Sheet for Patients
FDA Emergency Use Authorization
Emergency Use Authorization Letter