Biotin Found in Multivitamins May Interfere with Important Lab Tests Including hCG and Troponin Levels
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe how why biotin interferes with certain laboratory tests 2. Discuss the FDA recommendations for healthcare professionals regrading biotin and false positive and negative laboratory results
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 1/15/2020 through 07/15/2022, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
FDA has released a safety communication (November 2019) to alert health care professionals, lab personnel and consumers to the possible interference of biotin (vitamin B7, Vitamin H, Coenzyme R) with common, clinically significant lab tests, specifically troponin.
Biotin can readily be found in
Multivitamins, including prenatal multivitamins
Supplements for hair, skin, and nail growth
Impact of Biotin on Troponin Levels
Troponin is a key biomarker for detecting myocardial necrosis and assessing acute ischemic changes observed with acute coronary syndrome (ACS) and myocardial infarction
The FDA has received adverse events reports indicating that biotin can lead to false negative results
Some companies have addressed this risk while others have not
While this most recent safety communication is specific to troponin, the FDA does state that “biotin can cause falsely high or falsely low results” in other lab tests as well
For example, both false positive (FT4 and FT3) and false negative (TSH) thyroid studies have occurred due to elevated biotin levels
One other important example where interference has been documented is hCG pregnancy testing
Biotin can lead to false negative hCG results for both blood and urine pregnancy tests
Interference is related to the fact that biotin is a component of certain lab tests, specifically immunoassays based upon biotin-streptavidin interactions
Biotin interference appears to be dose dependent
Daily recommended allowance for biotin (0.03 mg) should not interfere with lab tests
However, there has been an increase in use of biotin supplementation
Levels higher than the daily recommended allowance may result in lab test interference
Some OTC supplements are available with biotin doses >1 mg, particularly those formulations that are marketed around hair, skin and nail quality
Biotin, up to 300 mg day, may be used by patients with multiple sclerosis
At this point in time, FDA is calling on both the healthcare community and consumers to be aware of false testing results, particularly for troponin
In addition, the FDA has released a list of troponin bioassays that may be subject to interference
Stopping biotin prior to lab testing
The Alberta Health Services and some health centers in Canada (see Sunnybrook Health Sciences Centre in ‘Learn More – Primary Sources’ below) have sent out an alert and recommend that biotin use be stopped prior to pregnancy testing, troponin and other lab studies if possible | If testing cannot be delayed, the relevant lab should be notified
Pudek et al. (BCMJ, 2019) recommend stopping biotin 24 hours prior to testing and 1 week if taking high dose
½ life of 0.6 mg biotin dose: <2 hours
½ life of 100 mg to 300 mg: Between 8 and 19 hours
The FDA, however, states that “sufficient information is not available to know if stopping biotin consumption for any number of hours prior to testing will prevent incorrect test results”
Healthcare professionals should be aware and speak to patients about risk of biotin interference with multivitamin supplements (including prenatal) and supplements for hair, nail and skin improvement
In addition, the FDA recommends that healthcare professionals
Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient’s specimen
Communicate to the lab conducting the testing if your patient is taking biotin
If a lab test result does not match the clinical presentation of your patient, consider biotin interference as a possible source of error
Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan