Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
This guidance provides recommendations for testing biotin interference in In Vitro Diagnostic Devices (IVDs) that use biotin/avidin technology. It aims to help device developers and clinicians understand how to perform biotin interference testing and communicate results to end-users.
Recommended Actions
- Implement biotin interference testing following CLSI EP07 guidelines
- Test biotin interference up to 3500 ng/mL concentration
- Determine the no-interference concentration level for susceptible assays
- Update device labeling to include comprehensive biotin interference information
- Contact FDA if interference is found at clinically relevant concentrations
- Develop additional mitigation strategies beyond labeling if significant patient risk exists
- Ensure test samples include analyte levels near medical decision points
- Document and communicate all interference testing results to end-users
Key Considerations
Clinical testing
- Samples should include analyte levels near medical decision point(s)
- Testing should follow designs similar to CLSI EP07 guidelines
- Biotin should be evaluated up to 3500 ng/mL (3x maximum expected clinical concentration)
Labelling
- Must include information on biotin interference
- Should state percent difference or bias at each concentration tested
- Should indicate consequence of biotin interference (falsely elevated/depressed)
- Should communicate findings to clinical laboratories and clinicians
Safety
- For assays susceptible to biotin interference at concentrations less than 3500 ng/mL, determine the concentration at which no interference is detected
- Additional mitigation strategies may be needed when risk of incorrect results could significantly affect patient health
Other considerations
- Sponsors should contact CBER or CDRH review division if biotin interference is demonstrated at clinically relevant concentrations
- Labeling alone may not be sufficient to mitigate risks in all cases
Relevant Guidances
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
Related references and norms
- CLSI EP07: Interference Testing in Clinical Chemistry; Approved Guideline
Original guidance
- Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
- HTML / PDF
- Issue date: 2020-10-16
- Last changed date: 2021-06-11
- Status: FINAL
- Official FDA topics: Medical Devices, Blood, IVDs (In Vitro Diagnostic Devices), Biologics, Blood Products
- ReguVirta summary file ID: 2afbc35ebbc2998543363ca7ac2da721
This post is licensed under CC BY 4.0 by the author.