Biotin interferences: Have we neglected the impact on serological markers?

Clin Chim Acta. 2020 Apr:503:107-112. doi: 10.1016/j.cca.2020.01.012. Epub 2020 Jan 21.

Abstract

Background: Biotin has been reported to be a leading cause of interference on several immunoassay platforms using the streptavidin-biotin immobilization system. While biotin interferences have now been well characterized for several assays, only few data are available on their impact on serological markers of infectious viral diseases.

Methods: Overall, 10 healthy volunteers (HVs) received a single 100 mg dose of biotin to evaluate its effect on hepatitis B serological markers. Blood samples were taken several times before and after biotin intake. In addition, spiking experiments were applied to investigate biotin's impact on anti-HIV/p24 Ag and anti-HCV antibody levels. Several procedures designed to overcome this interference were evaluated.

Results: Biotin intake resulted in a false-negative anti-HBs immunological status (<10 mIU/mL) in 40.0% of cases. According to our anti-HBc and anti-HBe results, biotin intake was associated with 90.0% and 80.0% of false positive results, respectively. At the theoretical biotin peak concentration following a 100 mg intake, 50.0% and 66.6% of anti-HIV and anti-HCV results were false negatives, respectively. All the procedures evaluated to overcome the interference were proven effective.

Conclusion: HBV, HCV, and HIV serological markers are likely to be highly sensitive to biotin. Our data confirm that the scope of biotin interference is broader than commonly described.

Keywords: AIDS; Biotin; Hepatitis; Interference; Serology; Virology.

MeSH terms

  • Adult
  • Antibodies, Viral / blood
  • Biomarkers / blood
  • Biotin / administration & dosage
  • Biotin / adverse effects*
  • False Negative Reactions
  • Female
  • HIV Infections / diagnosis
  • HIV Infections / immunology
  • Healthy Volunteers
  • Hepatitis B / diagnosis
  • Hepatitis B / immunology
  • Hepatitis C / diagnosis
  • Hepatitis C / immunology
  • Humans
  • Immunoassay / standards*
  • Male
  • Virus Diseases / diagnosis*
  • Virus Diseases / immunology

Substances

  • Antibodies, Viral
  • Biomarkers
  • Biotin