The use of our external run controls, NAT controls, panels and serology controls can help you create confidence, assure consistent molecular results and comply with ISO15189:2012 accreditation, which is an internationally recognised standard and a valuable resource for medical laboratories.
Benefits of ISO15189:2012
ISO 15189:2012 requirements state that the use of controls provided by third parties should be considered instead of using controls provided by the test manufacturer.
Our EXTERNAL RUN CONTROLS are designed to validate your molecular testing and are available for viral, bacterial, fungal and parasite detection at low and medium concentrations.
Our range of MOLECULAR CONTROLS and STANDARDS includes the NATtrol™ products (Nucleic Acid Testing Control), prepared from purified microorganisms or isolated from the plasma of infected individuals. The treatment modifies the surface proteins and renders the organisms non-infectious and refrigerator stable, while keeping it intact.
NATtrols™ are available as full process controls to monitor extraction and amplification steps, and are available in different formats, covering single and multiple analytes. They are open system so can be used across different molecular testing platforms and assays but some controls have also been developed in collaboration with leading platform manufacturers to optimize concentration levels :
|Alere Determine||Alere I||Bio-Rad HIV 1/2||BD Max||Fisher SureVue|
|BioFire FilmArray||Ortho Vitros Eci||Abbott Prism||Cepheid GeneXpert||Luminex xTAG Molecular|
|Luminex MAGPIX||Siemens Enzygnost||Roche Light Cycler 2.0-480||Roche||Nanosphere Verigene|