The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is intended for use by healthcare professionals or operators who are proficient in performing tests in POC settings. Users can check results visually within 15 minutes after collecting the nasal sample with a swab enclosed in the kit. Celltrion DiaTrust™ COVID-19 Ag Rapid Test shows increased sensitivity and high accuracy, as it detects both N and S antigens, unlike other products that mostly check for only one antigen.

Kit Contents

• Twenty-five (25) test devices packaged individually in aluminum pouch
• Twenty-five (25) disposable test tube with 0.3 mL of extraction buffer
• Twenty-five (25) filter cap
• Twenty-five (25) sterilized swabs for specimen collection
• One (1)  quick reference instruction
• Twenty-five (25) positive control swab
• Twenty-five (25) negative control swab

Performance Measures

• 86.1% Sensitivity
• 99.4% Specificity

Features

• Available for purchase with a valid CLIA waiver.
• This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2.
• Detects all known COVID-19 Variants
• Easy-to-read visual results available in 15 minutes
• Shelf-life of the test device is 18 months and is stable until the expiration date marked on the label.
• In some cases, the expiration date has been moved forward with the approval of the FDA.

360 Health Services Acceptable Product Dating

We will ship product with expiration dating >= 30 days from order date.

Attachments

• Celltrion FDA Letter of Authorization
• Celltrion Instructions for Use
• Celltrion Fact Sheet for HCP
• Celltrion Fact Sheet for Patients
• Celltrion EUA Revision 08.11.22
• Celltrion EUA Revision 11.04.22
• Celltrion DiaTrust COVID-19 Ag Rapid Test Shelf Life Extension
• FDA EUA Serial Testing Revision

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.