COVID-19 POC Test

DiaTrust™ COVID-19 Ag Home Test

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.

At Home Testing

NON-PRESCRIPTION HOME USE (OTC)

Fast Results

Simple to use and rapid results in 15 min

Accurate

86.7% Sensitivity and 99.8% Specificity

2 Tests / Box

Authorized Settings

Non-Prescription Home Use (Over the Counter)

Time for Result

Read results at 15 mins

Sample type

Mid-Turbinate Nasal Swab (NS)

Intended Use

Detection of Antigen from SARS-CoV-2

Clinical Sensitivity

86.7%
(95% CI: 73.8%-93.7%)

25 Tests / Box

Clinical Specificity

99.8%
(95% CI: 98.7%-100.0%)

Serial Screening

Yes

Variants

Anticipated to be reflective of the prevalent variants in
circulation at the time and location of the clinical evaluation

Shelf Life

12 Months

Manufactured in

Republic of Korea (South Korea)

Tests Per Pallet

2 Tests / Box = (1920 tests)
25 Tests / Box = (4800 tests)
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More Information

Spec
Sheets

FDA

The Celltrion DiaTrustTM 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-�, 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-1(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

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Celltrion USA

DiaTrust™ COVID-19 OTC Products