The ClearDetectTM COVID-19 Antigen Home 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
MaximBio ClearDetect COVID-19 Antigen Home Test 2-Test Pack. (Credit: PRNewswire / Maxim Biomedical, Inc)
Today, Maxim Biomedical (MaximBio), a leading diagnostic healthcare company and manufacturer of trusted diagnostic solutions announced a comprehensive Marketing and Distribution Agreement with Thomas Scientific for the ClearDetectTM COVID-19 Antigen Home Test (ClearDetectTM) which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration on January 19, 2022.
When asked about the collaboration, Anthony Morrison, MaximBio’s Chief Commercial Officer, 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.” Michael Brown, Senior VP, Clinical Diagnostics at Thomas Scientific, agreed, “For over a century, Thomas Scientific has been committed to offering quality laboratory products while catering to the unique needs of the individual customer. We are excited to add MaximBio’s innovative test to our product offering.”
The ClearDetectTM COVID-19 Antigen Home 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 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.
When compared to an EUA authorized PCR method, the MaximBio ClearDetectTM COVID-19 Antigen Home Test performed well, achieving 86.9% Positive Agreement (PPA) and 98.9% Negative Agreement (NPA), making it one of the more sensitive and specific antigen tests available. The test also performed admirably 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.
The test will be available in two kit configurations—packaged two (2) 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. Thomas Scientific will market both configurations and plans to price them competitively. MaximBio is currently ramping up production to meet the demand for COVID-19 testing and Thomas Scientific’s desire to fulfil customer needs.
Source: Company Press Release