The biotin interference within interference suppressed immunoassays

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Biochemistry

Background:

• Biotin supplementation is increasingly common, raising concerns about its interference with laboratory immunoassays.
• Immunoassay reliability is critical, as up to 70% of medical decisions depend on laboratory findings.

Purpose of the Study:

• To evaluate the reliability of immunoassays in the presence of biotin interference.
• To investigate the impact of biotin supplementation on laboratory test results.

Main Methods:

• Examined 59 interference-suppressed immunoassays from Roche Diagnostics for biotin interference sensitivity.
• Investigated biotin pharmacokinetics in volunteers supplemented with biotin.

Main Results:

• Biotin interference in laboratory findings is probable.
• Falsely elevated test results are more frequent than falsely low results in sandwich immunoassays, contrary to existing research.

Conclusions:

• Interference-suppressed immunoassays are susceptible to biotin interference.
• Laboratory professionals, medical staff, and patients must be aware of potential biotin interference.
• Roche Diagnostics should review interference suppression and test indications.