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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.

  1. Implement biotin interference testing following CLSI EP07 guidelines
  2. Test biotin interference up to 3500 ng/mL concentration
  3. Determine the no-interference concentration level for susceptible assays
  4. Update device labeling to include comprehensive biotin interference information
  5. Contact FDA if interference is found at clinically relevant concentrations
  6. Develop additional mitigation strategies beyond labeling if significant patient risk exists
  7. Ensure test samples include analyte levels near medical decision points
  8. 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

  • 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.