Trxade Group has filed for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in collaboration with its partnered manufacturer of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or when there are no adequate, approved, and available alternatives.
Filing the EUA has dual purposes; first it serves as notification to FDA that Trxade Group will be distributing the test and secondly, if the EUA is approved, it enables Trxade Group to market the product for diagnostic use. Currently, the test is intended to aid in presenting a qualitative overview of antibody presence in patients who have possibly been infected by the Coronavirus (COVID-19).
The rapid test is intended to be administered at the point of care with no additional instrumentation needed. Trxade has announced 20,000 units available for purchase as pre-orders as soon as April 10, 2020. The strategic partnership entered into by Trxade aims to scale distribution efforts to up to 1,000,000 units in order to supply healthcare facilities and provider offices nationwide to assist with providing value-based care.
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Features of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit:
- This rapid immunochromatography test provides qualitative detection of specific antibodies (IgM and IgG) found to match those of COVID-19 and is not meant solely for diagnostic purposes
- Tests are not meant for home use and should be performed under the supervision of a qualified healthcare professional
- The novel Antibody Rapid Test Kit begins working from blood drawn with a single pinprick, providing results within 15 minutes
- Negative test results do not rule out infection and follow-up testing with molecular diagnostics should be considered in patients with signs and symptoms or recent exposure to the virus