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COVID-19 Test Kit Using Portable Technology with Mobile App Result Reporting Secures FDA EUA

By LabMedica International staff writers
Posted on 07 Sep 2020
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Image: MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit (Photo courtesy of DetectaChem)
Image: MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit (Photo courtesy of DetectaChem)
A new groundbreaking COVID-19 test kit that uses portable technology along with mobile app result reporting has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit from DetectaChem (Sugar Land, TX, USA) 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.

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, Travis Kisner.

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