Features

• Test for both symptomatic and asymptomatic COVID-19
• Detects all known COVID-19 Variants
• QR code for result tracking on packaging
• Two Tests included for staggered testing over a 36 hour period
• Visual results available in 15 minutes

Celltrion DiaTrust™ COVID‐19 Ag Home Test Video (CLICK HERE)

Kit Contents

• Two (2) test devices
• Two (2) shallow nasal swabs
• Two (2) buffer solutions vials with caps
• Instructions for use

Performance Measures

• 86.7% Sensitivity
• 99.8% Specificity

Additional Information

• Celltrion OTC Fact Sheet for HCP
• Celltrion OTC FDA Letter of Authorization
• Celltrion OTC Instructions for Use (Home Test)
• Celltrion OTC Instructions for Use
• Celltrion OTC EUA Revision 11.04.22
• Celltrion OTC EUA Revision Serial Testing
• Celltrion OTC COVID-19 Ag Shelf Life Extension

Disclaimer

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.