Microbix has recently developed the COVID-19 Quality Assessment Products (QAPs) products below for External Quality Assessment and Proficiency Testing uses, for various Research Use Only (RUO) uses and when authorized, for IVD use. The products will be submitted to the US Food and Drug Administration for Emergency Use Authorization (EUA) and other major jurisdictions including Canada and the European Union, which also have similar expedited approvals processes. Once authorized, the products will be available for purchase for IVD use.
As for all Microbix QAPs, this COVID-19 product is a whole-genome workflow support tool that includes 100% of the genetic sequences of the virus and emulates real patient samples while being consistent, non-infectious, and stable. As such, it contains all possible NAT viral targets – ensuring compatibility across all current and future NATs. This broad compatibility and guaranteed utility is particularly relevant for External Quality Assurance Programs that assess and ensure the performance of testing labs.