- Microbix Biosystems Inc. (MBX) opens availability of its Quality Assessment Products as In-Vitro Diagnostic Controls – to monitor the workflow accuracy of antigen-based tests
- Antigen-based tests look for the intact or fragmented virus within a patient sample
- Microbix created its antigen-test QAPs to support laboratory proficiency-testing and accreditation, test development or staff training
- At present, Microbix’s REDxFLOQ SARS-CoV-2 Ag controls have confirmed compatibility with 27 different COVID-19 antigen tests
- Microbix Biosystems Inc. (MBX) is in the grey and is trading at C$0.59 at 12:15 pm EST
Microbix Biosystems announces the availability of more of its Quality Assessment Products (QAPs).
These Quality Assesment Products monitor the clinical lab workflow of antigen-based tests for the virus causing COVID-19 in Canada, the EU, and the United States.
Antigen-based tests look for the intact or fragmented virus within a patient sample, which can be taken and analyzed at the same point-of-care or a clinical laboratory.
Such tests prove to be a faster and less expensive option for widespread population-based COVID-19 screening.
However, they are not replacing lab-based nucleic acid testing for the definitive diagnosis of individuals.
Microbix created its antigen-test QAPs to support laboratory proficiency-testing and accreditation, test development or staff training, and to monitor clinical lab workflows.
External validation of these QAPs was completed in October 2020, with a Research-Use-Only “RUO” version of the product becoming available at that time.
Microbix has now completed the extensive “technical file” required for regulatory purposes to permit product usage for monitoring the accuracy of lab-based patient-testing workflows.
At present, Microbix’s REDxFLOQ SARS-CoV-2 Ag controls have confirmed compatibility with 27 different COVID-19 antigen tests, thereby providing a complete solution for health systems deploying multiple tests.
Microbix’s antigen-test QAPs are already being widely used for lab proficiency testing and accreditation, onboarding new instruments, and training technicians.
Such RUO uses are now joined by availability for supporting laboratory quality management systems.
Microbix’s antigen-test QAPs also complement its IVD COVID-19 PCR-test QAPs that have been successfully adopted to support proficiency testing, training, and quality management at clinical labs in Australia, the EU, North America, Scandinavia, and the UK.
Microbix remains committed to building its portfolio of innovative, proprietary, and branded QAPs – now at six IVD Controls for COVID-19 testing and six others for sexually-transmitted diseases (four HPV and two Mgen).
All Microbix QAPs, its COVID-19 antigen-test versions are optimized to assist quality management systems regardless of what specific tests are in use and additional to whatever onboard controls are used within particular tests.
As such, they supplement accuracy without risk to patients.
Cameron Groome, President and CEO, stated, “We welcome being able to make these antigen-test QAPs widely-available to monitor workflow accuracy at clinical laboratories.”
“I thank our internal product development, manufacturing, and regulatory teams, and also our collaborators for enabling us to provide healthcare systems with another important tool for helping to manage the COVID-19 pandemic,” concluded Groome.
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 90 skilled employees and sales growing from a base of over $1 million per month.
Microbix Biosystems Inc. (MBX) is in the grey and is trading at C$0.59 at 12:15 pm EST.
