DetectaChem Receives FDA EUA Authorization for Mobile COVID-19 Detection Technology
DetectaChem, the global leader in innovative portable threat detection technologies used daily by U.S. Homeland Security, Department of Defense and first responder agencies around the world, today announces their MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit has received FDA (Food and Drug Administration) EUA (Emergency Use Authorization).
The BCC19 test kit utilizes portable laboratory-grade diagnostic technology that can run up to 96 tests per device in just 30 minutes. The test detects nucleic acids from the 2019-nCoV virus to determine positive or negative results and then utilizes the free MobileDetect App for Apple and Android platforms to generate result reports with time, date, images, patient info, GPS mapping and more. Generated test reports can then be immediately sent via email or text to healthcare providers, laboratories or any other desired recipient. The BCC19 test kit achieved 100% positive and negative detection accuracy during FDA testing with comparable results and limits of detection to RT-PCR laboratory equipment.
Leveraging DetectaChem's experience in fully-integrated mobile solutions, the BCC19 test kit is also offered in a variety of Mobile Field Lab (MFL) configurations which contain up to 960 tests and all components needed for nasal or oral sampling and analysis in a single ruggedized and lightweight case. This unique option allows universities, schools, nursing homes, hospitals, police departments, emergency services and many others to deploy high-throughput mass testing solutions anytime, anywhere. As many testing sites can take 24 hours or much longer to produce test results, asymptomatic positive patients waiting for results can unknowingly infect countless others. With the BCC19 test kit's 30-minute cycle and diagnostic-level results, the window for spreading COVID-19 is drastically reduced from hours or days to minutes resulting in greater safety for organizations and their communities at large.
"Accurate, fast, easy-to-use, and widely accessible testing is crucial in enabling a safe return to normal life for organizations and individuals around the world and we're proud to provide the MD-Bio BCC19 kit as a solution," said DetectaChem COO, .
More information and ordering details can be found at www.MobileDetectBio.com.