Seaborg E. Thyroid month: beware of biotin. Endocrinol News. 2016;1:12-16.
Biotin: fact sheet for health professionals. National Institutes of Health website. https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/#en31. Updated March 2, 2018. Accessed May 21, 2018.
Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44:750-759.
Abdollai A, Saffar H, Saffar H. Types and frequency of errors during different phases of testing at a clinical medical laboratory of a teaching hospital in Tehran, Iran. N Am J Med Sci. 2014;6:224-228.
Sturgeon CM, Viljoen A. Analytical error and interference in immunoassay: minimizing risk. Ann Clin Biochem. 2011;48:418-432.
Dimeski G. Interference testing. Clin Biochem Rev. 2008;29(suppl 1):S43-S48.
Grimsey P. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. Int J Pharmacokinet. 2017;2:247-256.
Livaniou E, Evangelatos GP, Ithakissios DS, et al. Serum biotin levels in patients undergoing chronic hemodialysis. Nephron. 1987;46:331-332.
Trambas C, Lu Z, Yen T, Sikaris K. Characterization of the scope and magnitude of biotin interference in susceptible Roche Elecsys competitive and sandwich immunoassays. Ann Clin Biochem. 2018;55:205-215.
Holmes E. Biotin interference in clinical immunoassays: a cause for concern. Arch Pathol Lab Med. 2017;141:1459-1460.
Apple FS, Jaffe AS, Collinson P, et al; International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers. IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays. Clin Biochem. 2015;48:201-203.

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Moderator

Philip D. Levy, MD, MPH

Edward S. Thomas Professor
Associate Chair for Research
Department of Emergency Medicine
Assistant Vice President
Translational Science and Clinical Research Innovation
Wayne State University
Detroit, Michigan

Disclosures

Disclosure: Phillip D. Levy, MD, MPH, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Ortho Clinical Diagnostics; Roche Diagnostics; Siemens AG
Received grants for clinical research from: Roche Diagnostics

Dr Levy does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Levy does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Panelists

Jessica Colón-Franco, PhD, DABCC

Assistant Professor
Department of Pathology
Medical College of Wisconsin
Milwaukee, Wisconsin

Disclosures

Disclosure: Jessica M. Colón-Franco, PhD, DABCC, has disclosed no relevant financial relationships.

Dr. Colón-Franco does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Colón-Franco does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Kay Melching, MSA, RN, AACC, CPHQ

Case Manager/Utilization Review
Mt. Carmel Health System
Columbus, Ohio

Disclosures

Disclosure: Kay Melching, MSA, RN, AACC, CPHQ, has disclosed no relevant financial relationships.

Ms Melching does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Ms Melching does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Nam Tran, PhD, HCLD (ABB)

Associate Professor of Clinical Chemistry, Special Chemistry, and Toxicology
POCT and SARC Sections
Department of Pathology and Laboratory Medicine
University of California, Davis

Disclosures

Disclosure: Nam Tran, PhD, HCLD (ABB), has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Roche Diagnostics

Dr. Tran does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Tran does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Joy P. Marko, MS, APN-C, CCMEP

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Joy P. Marko, MS, APN-C, CCMEP, has disclosed no relevant financial relationships.

CME Reviewer(s)

Amy Bernard, MS, BSN, RN-BC

Lead Nurse Planner, Medscape, LLC

Disclosures

Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.

CME / ABIM MOC / CE

Optimizing Accuracy of Laboratory Testing: Team Based Strategies To Reduce Biotin Concerns

Authors: Phillip D. Levy, MD, MPH; Nam Tran, PhD, HCLD (ABB); Jessica M. Colón-Franco, PhD, DABCC; Kay Melching, MSA, RN, AACC, CPHQ
CME / ABIM MOC / CE Released: 6/19/2018
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 6/19/2020, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for cardiologist, emergency department physicians, primary care providers, and nurses.

The goal of this activity is to improve awareness of the risks of biotin effects on certain laboratory values and ways to mitigate biotin interference.

Upon completion of this activity, participants will:

Have increased knowledge regarding the
- Common sources of biotin intake
- Effect of biotin on the accuracy of different laboratory tests
Have greater competence related to implementation of team-based care to recognize and minimize the impact of biotin on laboratory testing

Disclosures

Moderator

Philip D. Levy, MD, MPH

Edward S. Thomas Professor
Associate Chair for Research
Department of Emergency Medicine
Assistant Vice President
Translational Science and Clinical Research Innovation
Wayne State University
Detroit, Michigan

Disclosures

Disclosure: Phillip D. Levy, MD, MPH, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Ortho Clinical Diagnostics; Roche Diagnostics; Siemens AG
Received grants for clinical research from: Roche Diagnostics

Dr Levy does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Levy does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Panelists

Jessica Colón-Franco, PhD, DABCC

Assistant Professor
Department of Pathology
Medical College of Wisconsin
Milwaukee, Wisconsin

Disclosures

Disclosure: Jessica M. Colón-Franco, PhD, DABCC, has disclosed no relevant financial relationships.

Dr. Colón-Franco does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Colón-Franco does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Kay Melching, MSA, RN, AACC, CPHQ

Case Manager/Utilization Review
Mt. Carmel Health System
Columbus, Ohio

Disclosures

Disclosure: Kay Melching, MSA, RN, AACC, CPHQ, has disclosed no relevant financial relationships.

Ms Melching does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Ms Melching does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Nam Tran, PhD, HCLD (ABB)

Associate Professor of Clinical Chemistry, Special Chemistry, and Toxicology
POCT and SARC Sections
Department of Pathology and Laboratory Medicine
University of California, Davis

Disclosures

Disclosure: Nam Tran, PhD, HCLD (ABB), has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Roche Diagnostics

Dr. Tran does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Tran does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Joy P. Marko, MS, APN-C, CCMEP

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Joy P. Marko, MS, APN-C, CCMEP, has disclosed no relevant financial relationships.

CME Reviewer(s)

Amy Bernard, MS, BSN, RN-BC

Lead Nurse Planner, Medscape, LLC

Disclosures

Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.

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From Medscape Education Cardiology

CME / ABIM MOC / CE

Optimizing Accuracy of Laboratory Testing: Team Based Strategies To Reduce Biotin Concerns

Authors: Phillip D. Levy, MD, MPH; Nam Tran, PhD, HCLD (ABB); Jessica M. Colón-Franco, PhD, DABCC; Kay Melching, MSA, RN, AACC, CPHQFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME / ABIM MOC / CE Released: 6/19/2018

Valid for credit through: 6/19/2020, 11:59 PM EST

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Optimizing Accuracy of Laboratory Testing: Team-Based Strategies to Reduce Biotin Concerns
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Slide 1.

Panel
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Slide 2.

Physicians Rely on Accurate Laboratory Results
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Slide 3.

Emerging Problem of Biotin Interference in Immunoassays^[1]
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Slide 4.

Dietary Sources^[2]
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Slide 5.

Laboratory Errors Can Occur in the 3 Phases of the Testing Process^[3,4,6]
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Slide 6.

Sources of Analytical Error in Clinical Immunoassays^[5,6]
- The laboratory may or may not question an unusual result
- It is very important to work collaboratively with different stakeholders across the institutions to understand these interferences
- Discuss and reach out to each other to develop strategies to mitigate possible risk for the patient
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Slide 7.

Biotin: Interference in Immunoassays^[1]
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Slide 8.

Noncompetitive Immunoassays
- Error: instead of having a high signal, the complexes are going to be washed off and the signal is going to be falsely low
- Biotin pulls the streptavidin-bound antibody away and it makes it appear as if the substance it is looking to detect is not there
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Slide 9.

Competitive Immunoassays
- In a competitive immunoassay format, in which there is a molecule competing for binding of the antibody, the same principle applies except that because the signal is indirectly proportional to the amount of analyte in the sample, the response will be falsely increased because the signal is not received
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Slide 10.

Noncompetitive vs Competitive Immunoassay
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Slide 11.

Interference Example^[7]
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Slide 12.

UCDMC Endocrinology Population^[8]
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Slide 13.

UC Davis Thyroid Testing Population
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Slide 14.

Biotin in TSH and Troponin Testing
- Most people in the UC Davis Sacramento area did not take any biotin
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Slide 15.

Biotin in TSH and Troponin Testing (cont)
- Various cancer biomarkers and even some point-of-care tests, such as human chorionic gonadotropin for pregnancy tests, can be affected
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Slide 16.

Affected Laboratory Testing^[9]
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Slide 17.

High-Sensitivity Cardiac Troponin Assay^[11]
- Next-generation troponin testing has recently been approved by the US Food and Drug Administration
  - This particular assay does have a biotin interference threshold
- Nam Tran, PhD, HCLD (ABB): I am comfortable and very happy to say that there were no patients in our study that came anywhere close to that interference threshold
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Slide 18.

UC Davis Summary
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Slide 19.

Key Point: Biotin Interference Is Preventable
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Slide 20.

Health History: Avoid Issues Later^[1]
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Slide 21.

Ask When Was Biotin Taken^[10]
- Both nurses and physicians need to be aware of timing and ask when the supplement was taken
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Slide 22.

Educate All Disciplines on Many Platforms
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Slide 23.

Multidisciplinary Team System Approaches
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Slide 24.

Key Takeaways: Clinicians' Responsibilities
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Slide 25.

Attention Emergency Medicine Clinicians
[ CLOSE WINDOW ]

Slide 26.

Rare But Be Aware
[ CLOSE WINDOW ]

Slide 27.

Thank you
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Slide 28.

This content has been condensed for improved clarity.

Practice Assessment

How will you improve your practice? Please click on the “Next” button to assess your planned changes in comparison with your peers by completing this brief survey. (Note: the following questions were developed by an independent consulting group with expertise in assessing the effectiveness of medical education.)

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The educational activity presented above may involve simulated case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient is intended or should be inferred.

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Moderator

Philip D. Levy, MD, MPH

Panelists

Jessica Colón-Franco, PhD, DABCC

Kay Melching, MSA, RN, AACC, CPHQ

Nam Tran, PhD, HCLD (ABB)

Editor

Joy P. Marko, MS, APN-C, CCMEP

CME Reviewer(s)

Amy Bernard, MS, BSN, RN-BC

CME / ABIM MOC / CE

Optimizing Accuracy of Laboratory Testing: Team Based Strategies To Reduce Biotin Concerns

Target Audience and Goal Statement

Disclosures

Moderator

Philip D. Levy, MD, MPH

Panelists

Jessica Colón-Franco, PhD, DABCC

Kay Melching, MSA, RN, AACC, CPHQ

Nam Tran, PhD, HCLD (ABB)

Editor

Joy P. Marko, MS, APN-C, CCMEP

CME Reviewer(s)

Amy Bernard, MS, BSN, RN-BC

Accreditation Statements

For Physicians

For Nurses

Instructions for Participation and Credit

Optimizing Accuracy of Laboratory Testing: Team Based Strategies To Reduce Biotin Concerns

Optimizing Accuracy of Laboratory Testing: Team-Based Strategies to Reduce Biotin Concerns

Slide 1.

Panel

Slide 2.

Physicians Rely on Accurate Laboratory Results

Slide 3.

Emerging Problem of Biotin Interference in Immunoassays[1]

Slide 4.

Dietary Sources[2]

Slide 5.

Laboratory Errors Can Occur in the 3 Phases of the Testing Process[3,4,6]

Slide 6.

Sources of Analytical Error in Clinical Immunoassays[5,6]

Slide 7.

Biotin: Interference in Immunoassays[1]

Slide 8.

Noncompetitive Immunoassays

Slide 9.

Competitive Immunoassays

Slide 10.

Noncompetitive vs Competitive Immunoassay

Slide 11.

Interference Example[7]

Slide 12.

UCDMC Endocrinology Population[8]

Slide 13.

UC Davis Thyroid Testing Population

Slide 14.

Biotin in TSH and Troponin Testing

Slide 15.

Biotin in TSH and Troponin Testing (cont)

Slide 16.

Affected Laboratory Testing[9]

Slide 17.

High-Sensitivity Cardiac Troponin Assay[11]

Slide 18.

UC Davis Summary

Slide 19.

Key Point: Biotin Interference Is Preventable

Slide 20.

Health History: Avoid Issues Later[1]

Slide 21.

Ask When Was Biotin Taken[10]

Slide 22.

Educate All Disciplines on Many Platforms

Slide 23.

Multidisciplinary Team System Approaches

Slide 24.

Key Takeaways: Clinicians' Responsibilities

Emerging Problem of Biotin Interference in Immunoassays^[1]

Dietary Sources^[2]

Laboratory Errors Can Occur in the 3 Phases of the Testing Process^[3,4,6]

Sources of Analytical Error in Clinical Immunoassays^[5,6]

Biotin: Interference in Immunoassays^[1]

Interference Example^[7]

UCDMC Endocrinology Population^[8]

Affected Laboratory Testing^[9]

High-Sensitivity Cardiac Troponin Assay^[11]

Health History: Avoid Issues Later^[1]

Ask When Was Biotin Taken^[10]