Microbix Antigen-test QAPs Now Available For Clinical Use

REDxFLOQ SARS-CoV-2 Antigen as IVD Controls in Canada, the EU, and the U.S.

MISSISSAUGA, Ontario, March 11, 2021 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix), a life sciences innovator and exporter, announces the availability of more of its Quality Assessment Products (QAPs) as In-Vitro Diagnostic “IVD” Controls – to monitor the workflow accuracy of antigen-based tests for the virus causing COVID-19 disease in Canada, the EU, and the United States.

Antigen-based tests look for intact or fragmented virus within a patient sample, which can be taken and analyzed at the same point-of-care or at a clinical laboratory. Such tests are proving to be a faster and less expensive option for widespread population-based screening for COVID-19 disease, although they are not replacing lab-based nucleic-acid (“NAAT” or “RT-PCR”) testing for definitive diagnosis of individuals.

Microbix created its antigen-test QAPs to support laboratory proficiency-testing and accreditation, test development or staff training, and monitoring of 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. The resulting IVD versions are branded as “REDxFLOQ SARS-CoV-2 Ag” positive and negative controls that are room-temperature stable for 12-months and formatted on COPAN FLOQSwabs. At present, Microbix’s REDxFLOQ SARS-CoV-2 Ag controls have confirmed compatibility with 27 different COVID-19 antigen tests, thereby providing a complete quality solution for health systems deploying multiple tests.

Microbix’s antigen-test QAPs are already being widely used and recommended 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 compliment its IVD COVID-19 PCR-test QAPs (REDxFLOQ SARS-CoV-2 & REDx Controls SARS-CoV-2) 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 continuing to build 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).