Microbix Biosystems Inc. develops and commercializes proprietary biological and technological solutions for human health and wellbeing. Microbix manufacture a wide range of critical biological materials for the global diagnostics industry, notably antigens used in immunoassays and Quality Assessment and Proficiency (QAPs™) testing products. QAPs™ designed to satisfy the full needs of current clinical Quality Management Systems (QMS) and Research Use Only (RUO) application. All QAPs™ are manufactured from native pathogens or synthetic whole genome of pathogens to be virtually identical to patient samples.
Quality Control for Molecular Diagnostics (QCMD) is an independent International External Quality Assessment (EQA) / Proficiency Testing (PT) organization. QCMD provides a wide-ranging quality assessment service primarily focused on molecular infectious diseases to over 2000 participants in over 100 countries.
The aim of EQA programmes is to help monitor and improve quality within the clinical laboratory by assessing a laboratory's ability to use molecular diagnostic technologies within the routine clinical setting. The reports and practical feedback QCMD provides participants allows them to identify and resolve potential problems whilst monitoring the effectiveness of their laboratory quality assurance processes.
Qnostics is a leading provider of molecular quality reagents and custom manufacture solutions. It specializes in the development, manufacture and distribution of Infectious Diseases Molecular Controls for use within the standard procedures of today’s molecular laboratory and Nucleic Acid Testing (NAT) assays. In addition to product supply, Qnostics has, since 2003 for more than a decade, been a service provider to molecular diagnostics in-vitro Diagnostic (IVD) assay manufacturers, EQA providers, Pharmaceutical and CRO organizations. The primary focus for the company is on infectious diseases, including the availability of hundreds of molecular characterized viral, bacterial and fungal targets.
Maine Molecular Quality Controls (MMQCI) designs and markets high-quality molecular controls for use in inherited disease testing, infectious disease detection, oncology and pharmacogenetics. Comprising of synthetic DNA/RNA suspension in non-infectious solution of buffers, preservatives and stabilizers, these quality controls manufactured in cGMP facility, are made to mimic clinical specimens under laboratory conditions. MMQCI's quality controls provide confidence in test results, it can monitor the entire molecular diagnostic test process, including the extraction, amplification and detection steps.
Commercial series is specifically made compatible with commercial test panels and systems such as BioFire FilmArray®, Cepheid GeneXpert®, GenMark Dx eSensor®, Luminex Verigene® and Curetis Unyvero A50