Medical Supply Company’s partner Microbix, are pleased to announce the creation, verification and imminent commercial availability of a quality assessment product (QAPTM) to help ensure the accuracy of COVID-19 disease testing.
Both, a room-temperature stable COVID-19 QAPs exclusively on COPAN® FLOQSwabs®, and a liquid format are available and can be shipped immediately to support the verification of new testing methods. Further regulatory authorisations are being sort on an emergency-use basis, and when granted, will permit the release of IVD-labelled versions of Microbix COVID-19 products for ongoing quality management systems.
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.
This new and innovative Microbix product has been shown to work with nucleic-acid based test (NAT) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically that published by the U.S. Centers for Disease Control (run at MBX) and of Seegene, Inc. (Allplex™ 2019-nCoV assay, run externally at KoronaDx).
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