DetectaChem has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its MobileDetect Bio (MD-Bio) BCC19 Covid-19 test kit.
The BCC19 test applies portable laboratory-grade diagnostic technology, which can run up to 96 tests per device in 30 minutes.
DetectaChem will identify nucleic acids from the 2019-nCoV virus for the determination of positive or negative results.
The free MobileDetect App, designed for Apple and Android platforms, will be used to generate result reports with time, date, images, patient information and GPS mapping.
Later, the generated test reports will be sent through email or text to healthcare providers, laboratories or any other desired recipient.
The BCC19 test kit is available in different MFL configurations
According to the company, 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.
DetectaChem provides a BCC19 test kit in different Mobile Field Lab (MFL) configurations, which include up to 960 tests and all components required for nasal or oral sampling and analysis in a single ruggedised and lightweight case.
The company’s mobile Covid-19 detection technology will help deploy high-throughput mass testing at universities, schools, nursing homes, hospitals, police departments and emergency services.
According to the company, the window for spreading Covid-19 is highly reduced from hours or days to minutes with the BCC19 test kit’s 30-minute cycle and diagnostic-level results.
DetectaChem COO Travis Kisnerm said: “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.”
In August, LumiraDx secured EUA status from the FDA for its point-of-care Covid-19 antigen test, which allows to detect antigen nucleocapsid protein from a nasal swab.
