Focus on In-house tests
Conditions to consider
When the manufacturer's validation isn't enough
A manufacturer's performance data may not fully apply when your laboratory changes how an IVD is used.
For example, you may be:
- Using a different specimen type
- Modifying sample preparation
- Changing an extraction process
- Using different instrumentation
- Altering analytical parameters
- Combining reagents or platforms
- Using an assay outside its intended purpose
- Developing your own laboratory method
- Using an RUO reagent within a clinical workflow
- Applying an established assay to a new clinical indication
In these situations, your laboratory needs to consider what evidence is required for your specific intended use.
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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
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
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.
Spotlight on ISO 15189 and In-House IVDR requirements
Your next steps as a medical laboratory
ISO 15189 specifically focuses on the unique requirements of medical laboratories and the significance should not be underestimated, especially in the field of public health. ISO 15189 was fundamentally revised at the end of 2022. It sets out more detailed requirements and emphasizes the importance of risk management even more strongly. Furthermore Vitro Diagnostic Medical Devices regulation (IVDR) now makes concrete demands on laboratories. A lot of medical laboratories are not fully aware of the existing and the new requirements. Lets review some of the main points:
In-house IVD: What are they? An IVD is “a laboratory developed test (LDT) that is designed, manufactured and used within a single laboratory or within health institutions established in the Union”. This includes any device used to examine or monitor humans, including “software or systems” connected to in vitro activity.
A medical laboratory can also create CE Marked devices to an LDT by:
- combining products or processes that are not intended for the combination, or
- uses a CE-IVD device outside its intended purpose, e.g., when they:
- misuse the device (off-label use) or
- modify commercial devices (including if they deviate from the instructions for use of conventional IVD devices).
What are Legal requirements for IVDR?
Laboratories must develop, manufacture and surveil their own Laboratory Developed Tests (largely) in conformity with the requirements of the IVDR depending on a product’s risk classification. There are four categories (A to D) with A representing the lowest risk and D the highest.
The use of commercially available IVD devices is preferred and laboratories can only offer their own LDTs if the devices on the market do not meet the required performance.
Your next steps as a medical laboratory?
- You first need to identify and determine your product/assay's risk classification.
- Comply with the additional requirements of Article 5 (5) of the IVDR. This in main requires a clinical validation.
- Expand your quality management system to include regulations of laboratory developed tests.
Analytical Performance
Precision
How consistently does the method produce results?
Accuracy / Trueness
How close are results to an appropriate reference or comparator?
Analytical Measurement Range
Across what range can the method provide reliable results?
Linearity
Does the method respond appropriately across the intended measuring range?
Detection Capability
Can the method reliably detect clinically relevant levels?
Analytical Specificity
Does the assay measure the intended target without significant interference?
Interference
Could endogenous or exogenous substances affect results?
Reproducibility
Does performance remain consistent across relevant operators, runs, instruments or time periods?
Clinical performance matters too
A method can perform well analytically and still require careful consideration of its clinical application.
Depending on the test, this may involve evaluation of:
- Clinical sensitivity
- Clinical specificity
- Positive and negative populations
- Clinically relevant decision points
- Representative patient populations
- Comparator methods
- Clinical concordance
- Intended clinical application
Accreditation Assistance for Diagnostic Laboratories
Validation documentation
Validation documentation
Validation documentation
Send us your data and we will analyse the data and compile the report to ISO 15189 requirements.
Audit/review
Validation documentation
Validation documentation
Review and or audit your processes before and perform gap analysis for ISO 15189 accreditation.
Assay validation
Assay validation
Assay validation
Full assay/instrument implementation;
From planning and testing to full report write up. This is the hassle free product for the entire process enabling you to concrete on your day to day activities.
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Assay validation
Assay validation
With our expert guidance, navigate the complexities of ISO 15189 and IVDR regulations to ensure your diagnostic devise meets the highest standards of quality and compliance.