Test for Active/Current Infection with rapid Antigen Tests.
- ** 25 TESTS PER BOX **
- 15 minute results
- FDA Authorized (EUA)
- For Home Use / Over-the-counter (OTC)
- Direct mid-turbinate swab samples
- Accuracy = 99.8% Neg % Agreement & 86.7% Pos % Agreement
** Shipping UPS Ground only (no expedited requests at this time)
** All sales are final. No Cancelations/Refunds/Returns **
SUMMARY & EXPLANATION
This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
25 test devices
25 assay buffer
25 extraction vials and caps
25 specimen collection swabs
1 instructions for use
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.