Over 70 proprietary SKUs This makes Microbix a leader in innovation for continued long term benefits at improved margins
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Helping Ensure Workflow Accuracy of Tests for COVID, Flu A, Flu B, and RSV
MISSISSAUGA, Ontario, Dec. 20, 2021 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include single-unit swab-formatted controls that simultaneously support PCR tests for SARS-CoV-2 (“COVID”), Influenza A (“Flu A”), Influenza B (“Flu B”), and Respiratory Syncytial Virus (“RSV”), four of the most-common causes of viral infectious respiratory illness globally.
Specifically, Microbix is commercializing In-Vitro Diagnostic (“IVD”) quality controls to support workflow accuracy of “multiplex” clinical laboratory PCR tests that detect COVID, Flu A, Flu B, and RSV from a single patient-sample. These innovative, proprietary, and branded controls provide a fully-compliant, comprehensive, and cost-effective quality management tool to help avoid the systemic errors that can be driven by technicians, consumables, or instruments. Users of this IVD control will include lab accreditation agencies, makers of tests oriented to clinical labs or point-of-care, and clinical labs or medical clinics.
This Microbix multiplex QAP is made using Copan® FLOQSwabs® – the optimal format for accuracy and point-of-care use, with room-temperature stability for 12 months. As for all Microbix’s QAPs, this latest IVD control contains all possible PCR targets and is validated on multiple test platforms. This new QAPs SKU is branded REDx™FLOQ® SARS-CoV-2/Flu A&B/RSV Swab Positive Control and is now available to support clinical laboratory quality management systems (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx®FLOQ® versions are now available for other markets, with REDx IVD versions to follow.
Microbix’s QAPs portfolio now consists of over 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 16 QAPs are available as REDx™ Controls for IVD use by clinical labs. In addition to QAPs to support PCR-based testing for each of these important respiratory illnesses, Microbix also has IVD QAPs to support antigen-based respiratory pathogen tests (e.g., REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of COVID-oriented QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens