BARDA is partnering with Detect, Inc. to develop an over-the-counter home test that identifies and distinguishes between SARS-CoV-2 and influenza A and B nucleic acid in less than 30 minutes using a single nasal swab.
Under this contract award, Detect seeks to advance the development of this next generation device, the Detect COVID/Flu Test, through additional studies required by the U.S. Food and Drug Administration (FDA) to potentially grant Emergency Use Authorization (EUA) and to request 510(k) clearance to market the test kits.
The Detect COVID/Flu Test includes a reusable Detect Hub (Detect’s reusable base station), a single-use cartridge, and an accompanying mobile application. Individuals can perform the test at home without requiring laboratory expertise or sophisticated equipment and receive results in less than 30 minutes.
Detect’s molecular test is designed to rapidly target and amplify nucleic acid sequences through a process known as isothermal amplification. Detect’s isothermal amplification chemistry amplifies nucleic acid sequences directly from patient samples without any pre-processing steps or expensive, complex instrumentation. The molecular test also contains proprietary biochemical reagents that enable SARS-CoV-2 and influenza identification faster than traditional PCR while maintaining accuracy at low viral loads, making it more sensitive than at-home rapid antigen tests. A modular cartridge, designed for multiplexing, will allow users to receive independent test results for influenza A, influenza B, SARS-CoV-2 and potential co-infection while also possessing the capability to quickly reprogram the test to identify new targets and/or pathogenic strains.
The Detect COVID/Flu Test is projected to have the capability to recognize all known SARS-CoV-2 Variants of Concern, including Omicron. Detect’s isothermal amplification design has the potential to also be optimized for performance across viral variants and for robustness in the event new variants emerge in the future.
The Detect COVID/Flu Test is intended to be an important home diagnostic tool to aid in pandemic response. The ability for an individual to differentiate between respiratory infections – which often present with similar symptoms – is crucial to guiding personal decisions related to illness and treatment management. This diagnostic test could help increase testing capacity and expand access to testing across the U.S. to more rapidly identify, isolate, and treat individuals with COVID-19 and influenza.
If granted EUA, and then subsequent 510(k) clearance by the FDA, the multiplex test could bring COVID-19 and influenza testing to the home setting, thereby providing valuable information to help individuals make more informed care decisions and seek treatment.