The Celltrion DiaTrust™ COVID-19 Ag Home Test is intended at OTC: Test in the comfort of your home.
The Celltrion DiaTrust™ COVID-19 Ag Home 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
OTC - Over the counter or at home use
and For Medical Professionals
The Celltrion DiaTrust™ COVID-19 Ag Home 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 15 minutes read processing time.
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
Read the result at 15 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.
The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. 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.
Fact Sheet for Healthcare Providers
Healthcare Provider Instructions for Use
Instructions for Use - SPA
Instructions for Use - EA
Celltrion DiaTrust™ Shelf-Life Extension Notice