Control Material specific to research & feasibility studies
Dedicated site specializing in providing controls to use in research and assay development projects
Custom made Controls are made to access in-housed IVD products. A common mistake is to use of CE marked controls in-house IVD protocols and or feasibility researches studies . Commonly commercial control are made with predetermined 'intended uses' and not entirely applicable to new developments
Focus on IQC for ISO 15189
IQC ISO15189 2022 Standard 7.3.7.2
IQC ISO15189 2022 Standard 7.3.7.2
The structure and content of ISO 15189:2022 have been revised.
For IQC Standards 7.3.7.2 focus is on specifications based on the intended clinical application of the examination.
Key Change
IQC ISO15189 2022 Standard 7.3.7.2
The IQC section has been expanded from three subclauses to seven (a-g) where ‘a’ is defined as:
a1) The intended clinical application of the examination should be considered, as the performance specifications for the same measurand can differ in different clinical settings.
IQC Design requirements
How to select IQC materials? To be fit for purpose!
When designing an appropriate QC strategy several risk factors need to be taken into consideration:
- High-risk tests with a large impact on the wrong result
- Tests used to support the clinician’s decision in isolation
- Tests acted upon immediately
How to select IQC materials? To be fit for purpose!
How to select IQC materials? To be fit for purpose!
- Stability concerning properties of interest.
- Matrix as close as possible to the examination method & as close as possible to the patient sample.
- Concentration levels at/near the clinical decision limits and, when possible, covering the measurement range.
Third-party quality control materials
Third-party quality control materials
Manufactured based on the intended clinical application specifications of the examination to monitor.
They are designed to deliver an unbiased and independent assessment of performance with any instrument or method, enabling laboratories to gain accreditation and ensure optimum performance and accuracy in clinical laboratory.
Become Compliant
Third-party quality control materials
Embed Third party controls in clinical testing to cover critical decision points to avoid testing accreditation noncompliance.
Remember, IQC is not just about compliance; it is about managing quality effectively. Implementing correct levels of IQC in a medical laboratory is essential to ensure accurate and reliable test results.