FDA grants DetectaChem EUA for mobile COVID-19 test

By LabPulse.com staff writers

September 8, 2020 -- The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to DetectaChem for its MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit.

The test kit uses portable laboratory-grade diagnostic technology that can run up to 96 tests per device in 30 minutes. BCC19 detects nucleic acids from the SARS-CoV-2 virus to determine positive or negative results, and then the free MobileDetect app generates result reports with time, date, images, patient info, GPS mapping, and more. The report can be sent via email or text to healthcare providers, laboratories, or any other desired recipient.

The test kit achieved 100% positive and negative detection accuracy during FDA testing and had comparable results and detection limits to reverse transcription polymerase chain reaction (RT-PCR) equipment, according to DetectaChem.

The BCC19 test kit is also offered in various mobile field lab configurations that contain up to 960 tests with all the necessary components for nasal or oral sampling, as well as analysis. The ruggedized, lightweight case allows universities, schools, nursing homes, hospitals, police departments, emergency services, and others the opportunity to test on a large scale.

In addition, the test's 30-minute cycle and diagnostic-level results reduce the window for spreading COVID-19 as patients receive their results more rapidly than with other tests.

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Last Updated ls 9/18/2020 1:59:01 PM

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