Maxim Biomedical receives EUA for ClearDetect COVID-19 antigen home test

pharmafile | January 26, 2022 | News story | Research and Development  

Maxim Biomedical have received an Emergency Use Authorisation (EUA) from the FDA for their new ClearDetect COVID-19 Antigen Home Test. MaximBio designed, tested, and will manufacture their new assay in the US to help meet the growing demand for home testing.

The test employs proven Lateral Flow Assay (LFA) technology with a simplified workflow that can easily be done at home without the need for equipment or a reader. The test’s unique format involves only three components – a swab, a test strip, and a test tube pre-filled with sample buffer. This removes the need for reagent measuring, or the need to handle dropper bottles as required with other card-based and self-test systems.

To conduct a test, a self-collected nasal swab is mixed with the sample buffer in the tube and the swab handle is snapped off. A test strip is added, and the tube is capped for incubation, reading, and safe disposal in one tube. Results are available within 15 minutes and the signal lines can be visualised for up to one hour, making the test swift and the result reviewable for a longer period than many LFA tests.

The test will be avilable in two kit configurations – packaged two tests in a box for convenient at-home use, and in a bulk 25-test pack amenable for healthcare settings, schools, workplaces, and other high-volume testing scenarios.

In a recent interview, Jonathan Maa, COO of Maxim Biomedical Inc. said, “Maxim Biomedical has always endeavoured to provide high quality testing where it would fulfil unmet needs.  COVID-19 represents an opportunity to apply our expertise in LFA for application in the home and at the point-of-care with an accurate and easy-to-use solution.”

Lina Adams

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