Laboratory-Developed Test (LDT) and Modified IVD Validation
Introducing a new IVD, changing analytical platforms, modifying a manufacturer's method or developing a laboratory-developed test can create complex validation challenges.
That's exactly where we can help.
Before investing time and resources in additional testing, speak to us about:
- What you are changing
- Why you are changing it
- How the test will be used
- What evidence you already have
- What evidence you believe is required
We can help you identify evidence gaps, establish acceptance criteria, design appropriate studies and prepare clear, traceable documentation to support implementation and laboratory quality requirements.
Develop the validation strategy, evidence and documentation needed to demonstrate fitness for the intended clinical use
Unsure what validation evidence your laboratory needs?
ISOCHECKS provides specialist support for laboratories developing, modifying or implementing non-standard diagnostic methods.
Many laboratories unknowingly create Laboratory Developed Tests (LDTs) or modified methods without completing appropriate validation activities.
What Evidence Does UKAS Expect?
A laboratory should be able to demonstrate:
✅ Validation Plan
✅Defined Intended Use
✅Precision Studies
✅Accuracy & Method Comparison
✅Linearity & Measuring Range
✅Reference Interval Verification
✅Cut-Off Verification
✅Sample Stability Studies
✅Interference Assessments
✅Measurement Uncertainty
✅Staff Competency Records
✅Risk Assessments
✅Validation Report & Approval
