Technical Note: Bimodal Negative Interference of Biotin in Roche IL-6 Immunoassay

Amitava Dasgupta1, Samir Khalil2, Tiffany Paddock2

  • 1Department of Pathology and Laboratory Medicine, University of Texas McGovern Medical School at Houston, USA Amitava.Dasgupta@uth.tmc.edu.

Insights

Biotin supplementation can interfere with Interleukin-6 (IL-6) testing in COVID-19 patients, potentially affecting treatment decisions. The Roche IL-6 assay showed negative interference, particularly at 100 ng/mL biotin levels.

Area of Science:

  • Clinical Chemistry
  • Immunology
  • Biochemistry

Background:

  • Interleukin-6 (IL-6) is a critical biomarker for managing COVID-19 patients, guiding decisions on tocilizumab therapy and mechanical ventilation.
  • The Roche IL-6 assay uses biotinylated antibodies, raising concerns about potential interference from biotin supplementation.

Purpose of the Study:

  • To investigate the interference of biotin on the Roche IL-6 assay.
  • To determine the impact of biotin levels commonly found in patients on IL-6 measurements.

Main Methods:

  • Serum pools with IL-6 levels >40 pg/mL were prepared.
  • Pools were supplemented with varying biotin concentrations (25, 100, 1000 ng/mL).
  • IL-6 levels were re-assayed using the Roche IL-6 assay on a Cobas e411 analyzer.

Main Results:

  • Biotin demonstrated negative interference with the Roche IL-6 assay.
  • Maximum negative interference occurred at 100 ng/mL biotin.
  • No interference was observed at 25 ng/mL biotin, but interference was noted at 1000 ng/mL.

Conclusions:

  • Biotin interference can impact IL-6 assay results.
  • Assay results may be unreliable in patients taking biotin supplements.
  • Careful consideration of biotin intake is necessary when interpreting IL-6 levels.
Abstract

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