FDA authorizes mobile COVID-19 test kit

The FDA has issued emergency use authorization (EUA) for a mobile COVID-19 test kit developed by handheld detection system maker DetectaChem.

Stafford, Texas-based DetectaChem develops the MobileDetect Bio BCC19 test kit is designed to test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs and oropharyngeal swab specimens.

The test kit utilizes a reverse transcription loop-mediated isothermal nucleic acid amplification technique, according to a letter from the FDA. The sample is added directly to reaction tubes with reagent buffers without the need for separate lysis buffers or additional extraction steps.

As part of the testing kit, DetectaChem’s MobileDetect Bio subsidiary included a mobile app which runs the test and analyzes the sample within minutes, according to MobileDetect Bio’s website.

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