The Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor-binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset.

This test is also authorized for non-prescription home use with self-collected and adult-collected mid-turbinate swab samples from individuals 14 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days for at least 24 hours (and no more than 48 hours) between tests. 

• FDA EUA-AUTHORIZED HOME TEST (OTC): Celltrion DiaTrust COVID-19 Ag Home Test is an FDA EUA-authorized COVID-19 rapid antigen at-home testing kit. Self-test in the comfort of your own home, and get the relief you need, fast. For use in individuals aged 14 years and older.
• TWO TESTS PER KIT: Each kit contains supplies for two tests: swabs, test devices, test tubes (extraction buffer), filter caps, and an Instructions for Use manual. Test tubes and filter caps for two tests are enclosed in one inner package.
• RAPID RESULTS AND PERCENTAGE: The test gives you results in just 15 minutes and is authorized for at-home use without submitting sample collection to labs. Our home test can detect COVID-19 with 99.8% Negative Percent Agreement and 86.7% Positive Percent Agreement.
• SIMPLE STEPS: Just four steps from start to finish. The DiaTrust system makes getting your results easy. Test yourself and a family member at the same time or take two tests in a designated timeframe for travel, work, and more.
• SWAB WITH SOFTNESS: Our products prioritize user comfort, utilizing flock swabs with a softer tip that doesn’t irritate your nasal passages.

DiaTrust COVID-19 Ag Home Test IFU

DiaTrust COVID-19 Ag Home Test IFU for HCP

DiaTrust COVID-19 Ag Home Test Fact Sheet for HCP

DiaTrust COVID-19 Ag Home Test Box Labels

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.