CareStart Covid-19 Antigen At-Home Test

Emergency Use Authorization

https://assets.website-files.com/60be1a26622a3aabb72751b8/60cb7288d79801a32d574b64_EUA-accessbio-CareSAntigen-letter%20(1).pdf

Provider Fact Sheet

https://www.fda.gov/media/142917/download

Individual Fact Sheet

https://www.fda.gov/media/142918/download

Instructions for Use

https://assets.website-files.com/60be1a26622a3aabb72751b8/60be3f64d8d265e0aab33a52_EUA202625-S004-ABI-CareStart-COVID-19-Ag-Final-IFU-QRI_20210428.pdf

FDA Approval

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 and pathogens; and,
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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

When do I need to get tested for Covid-19?

You should take a Covid-19 test if you are experiencing flu-like symptoms.

Will a Covid-19 test protect me from Covid?

Covid-19 testing won't prevent you from getting Covid-19, but will let you know if you have Covid-19.

What does this test consist of?

Your CareStart Covid-19 test kit will include 2 test devices, 2 nasopharyngeal swabs, 2 tubes, 2 tube caps, and 1 set of instructions.

How long does this test take?

Performing your at-home Covid-19 test takes around 5 minutes to complete.

How will I receive my Covid-19 test kit?

Your test kit will be shipped to your address through FedEx.

How will I receive my results?

Your CareStart Covid-19 Antigen rapid test results are ready within minutes of completing the necessary steps included in the instructions.

What documentation will I need to get this Covid-19 test?

Your name, address, and phone number are necessary to deliver your test kit to you. No other documentation is required.

Celtrion DiaTrust Covid-19 Antigen POC Test