InBios COVID-19 Antigen Self-Test: SCoV-2 Ag Detect™ Rapid Self-Test

FDA Emergency Use Authorized

The SCoV-2 Ag Detect™ Rapid Self-Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen. The test can be performed using anterior nasal (nares) swab samples collected without transport media, requires no training and takes ~20 minutes to obtain results, making it a suitable diagnostic tool for use at home use.

The nasal swab test, designed to be extremely simple to use for consumers who are not familiar with self-testing, may be used by individuals 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

The SCoV-2 Ag Detect™ Rapid Self-Test kit features the same SARS-CoV-2 rapid antigen test that received an EUA from the FDA for use in professional settings in May 2021. The test, which is currently available in a two test per kit configuration, features a unique ease-of-use patent-pending design and uses shallow nasal swabs with no instrumentation required to read results. It is designed for use with symptomatic and asymptomatic serial testing.

DOCUMENTATION AND VIDEOS

InBios COVID-19 Antigen Self-Test brochure, package inserts, authorized FDA letter and additional literature provided below:

Rapid Self-Test Instructions

Healthcare Provider Fact Sheet

Healthcare Provider Instructions for Use

FDA EUA Letter of Authorization

Serial Testing Letter

Intended Use Modification

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 SARS1CoV-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.