UNMATCHED ASSURANCE IN QC
Getting Molecular Diagnostics Right Means External, Third-Party, IVD Quality Control
A staggering 70% of healthcare decisions depend on results from clinical diagnostic testing. Misdiagnosis can mean misguided treatment protocols. Any compromise in QC can jeopardize patient outcomes and expose the laboratory to unnecessary risks. To ensure accurate results, QC should be (1) External, (2) Third-Party, (3) IVD.
WHY EXTERNAL CONTROLS?
External controls: stand-alone controls, non-integrated controls
Many assays contain built-in controls to demonstrate they are ready for use. Typically, an integrated control confirms only the assay’s operability, not its accuracy. Only an external control can monitor and challenge every step of the assay process, from sample handling to detection. ISO 15189 states that a “laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples.”
WHY THIRD-PARTY CONTROLS?
Third-party controls: independent of the assay manufacturer
Optimal quality control puts every possible variable to the test. When used for routine QC, assay manufacturer-supplied control materials may amplify bias, rather than eliminate it. Assay manufacturer-supplied controls are often made of the same materials as assay reagents and calibrators. Only external controls produced by independent, third-party manufacturers fulfill the basic goal of QC by providing comprehensive, objective performance assessments for the assays and procedures.
WHY IVD CONTROLS?
IVD controls: products labelled for In Vitro Diagnostic use
The in vitro diagnostics (IVD) label represents the extensive validations required to be registered with FDA, European Commission, MHRA, and other regulatory bodies for an intended use in clinical diagnostics1,2. By contrast, RUO (Research Use Only) materials are in the laboratory phase of development and not approved for clinical diagnostic use3,4. Thus, RUO materials are not intended to confirm the accuracy of a diagnostic procedure that will impact patient treatment. An IVD label signifies exactly what you look for in an external, third-party control: uncompromising quality, according to the highest standards.
Despite these definitions, many laboratories may not know if their Dx materials are designated for RUO or if they're labelled for IVD use, inadvertently putting both patients and the laboratory at risk. We partnered with CAP Today and industry expert Dr. Sebastian Grömminger for a webinar highlighting the critical differences between RUO and IVD and the importance of choosing the right clinical diagnostic products.
CHECK OUT THE WEBINAR ON-DEMAND
IVD vs. RUO - Is Your Laboratory Relying on the Right Products?
VIDEO RESOURCES
External Controls for Diagnostic QC
Third Party Controls for Clinical Diagnostics
The Unmatched Confidence of IVD Labelled QC
Is Your QC Formatted Like a True Patient Sample?
THE BENEFITS OF OPTIMAL QC
It costs far less to do the job right the first time than to recover from error — especially when cost gets measured in patient health. In a quality assurance budget, quality controls form the least expensive but most critical layer of quality management. By trusting your QC to External, Third-Party, IVD controls, you minimize risks, while providing the highest accuracy at the lowest costs.
WHY MICROBIOLOGICS
Microbiologics creates “Confidence in Science,” through extensively validated QC materials trusted throughout the world for uncompromising precision. As an independent, third-party, IVD quality control manufacturer, Microbiologics adheres to regulatory requirements and invests in quality standards (i.e., ISO 13485:2016, ISO/IEC 17025:2017, ISO17034:2016, IVDR)5. Microbiologics products are traceable to reference standards and recommended by assay manufacturers.
INFECTIOUS DISEASE MOLECULAR STANDARDS THAT STREAMLINE YOUR QUALITY CONTROL
Helix Elite IVD Molecular Standards
Microbiologics quality controls are designed to be processed like patient samples to provide the most comprehensive monitoring of sample handling and assay performance. To meet the complex needs of laboratories, we offer a wide range of formats—from synthetic nucleic acid RNA and DNA sequences to inactivated, fully intact whole organisms. Our simple, accurate, and reliable IVD controls are compatible with a variety of instruments and assays.
We offer a broad selection of single-target and multiplex panels for diverse pathogens in easy-to-use formats. Our comprehensive line of molecular quality controls spans the following syndromic groups:
- Blood Culture Identification
- Emerging Diseases and Other
- Gastrointestinal (GI)
- Healthcare Associated Infections (HAIs)
- Respiratory
- Women's Health and STIs
THE MICROBIOLOGICS ADVANTAGE
- Lyophilized swabs or pellets allow you to “Hydrate and Go” – No need for temperature equilibration
- 2-25° C storage: Frees up refrigerated storage space and provides economical shipping options
- Long shelf-life: Minimizes lot-to-lot changes and corresponding studies
1Center for Devices and Radiological Health. (2021, October 21).Overview of IVD Regulation. U.S. Food and Drug Administration.
221CFR809, Subpart B In Vitro Diagnostic Products for Human Use. eu/docsroom/documents/10292/attachments/1/translations
3European Commission. (2004, February).Guidance document - In vitro diagnostic medical devices - Research Use Only products - MEDDEV 2.14/2 rev.1. European Commission.
4Center for Devices and Radiological Health. (2013, November 25). Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. Guidance for Industry and Food and Drug Administration Staff.U.S. Food and Drug Administration
5ISO 15189:2012. Medical laboratories – requirements for quality and competence. Clause 5.6.2.2 Quality Control Materials.
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