Biotin and the risk of false lab test results

Learn about biotin and how it can interfere with many lab tests to cause false test results.

On this page

• About biotin
• Risk of false lab test results with biotin
• What you can do
• Report a problem or concern
• Learn more about medical device safety in Canada

About biotin

Biotin is a vitamin (also known as biotine, vitamin B7, vitamin H or coenzyme R).

It's found in:

• medications
• dietary supplements
  • multivitamins
  • prenatal vitamins
  • supplements marketed for hair, skin and nail benefits

Many dietary supplements and medications contain high doses of biotin.

Risk of false lab test results with biotin

People who take supplements or medications containing high doses of biotin are at risk of receiving a misdiagnosis. That's because many lab tests use biotin technology to detect certain health conditions. High doses of biotin in the patient sample can interfere with how these tests function and cause falsely high or falsely low results.

False lab test results in clinically significant tests, such as troponin tests that help to diagnose heart attacks, can lead to serious health consequences.

Health Canada is aware of 1 death reported in another country, where a patient taking high levels of biotin died following false troponin test results. We have not received reports of Canadian cases of serious adverse events related to biotin interference with lab tests to date. Biotin can also interfere in other lab tests, such as some thyroid function hormone tests.

The recommended amount of biotin for adults is about 30 μg (or 30 micrograms) a day. Taking biotin in these quantities does not generally cause interference with lab tests.

Learn more:

• Dietary reference intake

What you can do

Patients, health care providers and lab personnel can take steps to reduce the risk of biotin causing false lab results.

Patients

Know what is in the supplements and medications you're taking.

Talk to your doctor if you're taking, have recently taken or plan to take medication or supplements that contain biotin in levels higher than the dietary reference intake of 30 μg (or 30 micrograms) a day recommended for adults.

Also talk to your doctor if you:

• have questions or concerns about the results of a lab test
• want to know how to manage the risk of biotin interfering with lab tests

Health care providers

Be aware that high biotin levels can interfere with many lab tests that use biotin technology, including troponin tests and thyroid function hormone tests.

When ordering a lab test:

• ask your patients about any medications or supplements they're taking that may contain biotin, including supplements marketed for hair, skin and nail benefits
• let the lab know if your patient is taking medications or supplements that contain high levels of biotin
• report confirmed or suspected cases of misdiagnosis or inappropriate patient management due to biotin interfering with lab tests to Health Canada

Laboratory personnel

If your lab uses tests with biotin technology:

• tell health care providers if your lab tests are susceptible to biotin interference and what can be done to address this risk
• follow the instructions for use provided by the manufacturer
  • if the product labelling does not address the issue, ask the manufacturer if their device is susceptible to biotin interference and, if so, how to manage the risk

Report a problem or concern

It's important to report any issues with a medical device, including adverse events.

Report a medical device problem:

• Consumer
• Hospital
• Health care provider

Learn more about medical device safety in Canada

We provide many sources of information on medical device safety and risks, including:

• medical device safety information
• MedEffect Canada, where we post the results of our safety reviews
• MedEffect e-Notice, where you can subscribe to receive health product safety alerts automatically
• recalls and safety alerts, where:
  • we post medical device recalls
  • you can subscribe to receive information on safety risks associated with medical devices
• medical device incidents database
  • be sure to read the disclaimer about the database's limitations
• summaries of decisions, where we provide health care providers with background information that could be relevant in treating their patients