Diagnostic solutions manufacturer Maxim Biomedical (MaximBio) announced a comprehensive marketing and distribution agreement with Thomas Scientific for the ClearDetect COVID-19 Antigen Home Test, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
The ClearDetect COVID-19 Antigen Home Test employs proven Lateral Flow Assay (LFA) technology with a simplified workflow that can be done at home. The test’s format involves only 3 components—a swab, a test strip, and a test tube pre-filled with sample buffer. This eliminates reagent measuring or the need to handle dropper bottles as required with other card-based and self-test systems.
MaximBio is currently ramping up production to meet the demand for COVID-19 testing and Thomas Scientific’s desire to fulfil customer needs.
When compared to an EUA authorized PCR method, the MaximBio ClearDetect COVID-19 Antigen Home Test performed well, achieving 86.9% Positive Agreement and 98.9% Negative Agreement. The test also performed well when evaluated by the NIH with specimens positive for the Omicron variant, detecting 100% of live virus Omicron samples diluted to a PCR Ct value of 25.8. In the same study the assay detected the Omicron variant at a higher dilution than two other EUA-approved antigen tests.
“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,” Anthony Morrison, MaximBio’s chief commercial officer, says of Thomas Scientific.
The test will be available in two kit configurations—packaged two tests in a box for convenient at-home use, and in a bulk 25-test pack amenable for high-volume testing scenarios.
“For over a century, Thomas Scientific has been committed to offering quality laboratory products while catering to the unique needs of the individual customer,” says Michael Brown, senior VP, clinical diagnostics at Thomas Scientific. “We are excited to add MaximBio’s innovative test to our product offering.”
Featured image: MaximBio ClearDetect COVID-19 Antigen Home Test 2-Test Pack. Photo: Maxim Biomedical