Diagnostic healthcare company Maxim Biomedical (MaximBio) has signed a marketing and distribution agreement with Thomas Scientific for its ClearDetect COVID-19 Antigen Home Test.
The antigen test received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) this month.
It is designed to detect SARS-CoV-2 proteins from nasal swab samples and provide results within 15 minutes.
The test uses Lateral Flow Assay (LFA) technology and can be performed easily at home without requiring equipment or a reader.
The ClearDetect COVID-19 Antigen Home Test involves only three components, specifically, a swab, test strip and test tube that comes pre-filled with sample buffer.
MaximBio stated that the test achieved 86.9% positive agreement and 98.9% negative agreement in comparison to a EUA authorised PCR method.
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It detected 100% of live virus Omicron samples when assessed by the National Institutes of Health (NIH) with positive specimens for the Omicron variant.
The antigen home test detected the variant at a higher dilution compared to the other two EUA-approved antigen tests in the same study.
MaximBio chief commercial officer Anthony Morrison said: “Their dedication to provide the best products with personal, efficient service makes them an ideal partner for MaximBio as we team up to help meet the growing demand for Covid-19 testing.”
The ClearDetect COVID-19 Antigen Home Test will be available in two kit formats, either a two test pack for at-home use or bulk 25-test pack for healthcare settings, workplaces, schools and other high-volume testing scenarios.
Under the deal, Thomas Scientific will offer both kit formats and plans to price them competitively.
Furthermore, MaximBio is increasing its production to meet Covid-19 testing demand.