On May 12, 2021, InBios announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Ag Detect Rapid Test. This is one of the simplest rapid antigen tests to use currently available that has been granted an EUA. It requires no instrumentation or transport media and can be performed on-site with results delivered in less than 30 minutes. The lateral flow immunoassay is intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct nasal swab specimens.

The point-of-care test is useful for evaluation of symptomatic and asymptomatic individuals. It can be used for those who are suspected of COVID-19 by their healthcare provider within five days of symptoms onset or for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. The kit contains 50 tests and swabs, positive and negative controls, and can be stored at room temperature.

The clinical performance of SCoV-2 Ag Detect Rapid Test was evaluated in a multi-site prospective study in the U.S., which showed that the test accurately determined 86.67% of those who were positive (PPA) and 100% of those who were negative (NPA) for SARS-CoV-2. Additionally, the SCoV-2 Ag Detect Rapid Test showed no cross-reactivity with common pathogens found in respiratory samples. Performance is reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.

Funding to achieve EUA for the SCoV-2 Ag Detect Rapid Test comes in part from a $12.7 million contract with the U.S. Army Medical Material Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Program Management Office with funding provided by the Defense Health Agency (DHA) through the CARES Act and the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response awarded in 2020 under contract W81XWH-16-D-0009/Task Order W81XWH-20-F-0253.

InBios’ other EUA COVID-19 products include the Smart Detect SARS-CoV-2 rRT-PCR Kit, and the SCoV-2 Detect IgG and IgM ELISA kits. InBios is also developing additional COVID-19 tests.

While the SCoV-2 Ag Detect Rapid Test has not been FDA cleared or approved, it has been authorized for use by the FDA under an EUA for use by authorized laboratories. An EUA permits use of certain medical products that may be effective during a public health emergency, which was declared for COVID-19 on Jan. 31, 2020. 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. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC) in patient care settings operating under a CLIA Certificate or Waiver, Certificate of Compliance or Certificate of Accreditation. The SCoV-2 Ag Detect Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.