Understand.
Inform.
Educate.
Providing laboratory professionals with education on biotin and other interferences.
As you are likely aware, there has been an increase of biotin usage across the country. Biotin can be found in a variety of products — e.g., multivitamins, and hair, skin, and nail supplements. Biotin, also called vitamin B7 or vitamin H, is a water-soluble vitamin of the B complex.
The following categories characterize the typical patient biotin dosing levels. There are three dosing categories outlined in the infographic below illustrating the amount of biotin each dose contains (mcg):
mcg/day
No recommended daily intake (RDI) exists, as deficiencies are rare
mcg/day
More than 125 times the suggested intake
mcg/day
Doctor-directed for specific patient populations
Standard multivitamin intake of biotin (30-60 mcg) poses no risk of interference. Very high doses, more than 5,000 mcg per day, do have the potential to lead to test interference. Because biotin deficiency is very rare, there is no official recommended daily intake for biotin in the U.S. Suggested intake for adults ranges from 30 to 100 mcg.1
1. Livaniou E, Nephron 46, 331–332 (1987); 2. Clevidence BA, Nutr. Res. 8, 1109–1118 (1988);
Streptavidin and biotin naturally form a strong, highly specific, stable bond. This design has been used by many in-vitro diagnostic manufacturers to create sensitive, accurate immunoassays.
Roche takes pride in our immunoassay design, with its foundation of a streptavidin — biotin interaction, enabling clinical confidence in results.
This trusted design offers features you require with your in-vitro diagnostics solutions to confidently test patients such as:
Biotinylated capture antibody; analyte and ruthenylated antibody form a sandwich.
Biotinylated capture antibody; analyte from the samples and ruthenylated analyte are incubated.
Roche is dedicated to providing innovation and quality products to our customers. As of September 2019, biotin will no longer be a distraction for our customers as we begin to launch next version immunoassays with an increased biotin threshold.
Elecsys TSH v2 assay is now available and contains a biotin threshold tolerance of 1200 ng/mL. The availability of the new Elecsys TSH v2 assay with the increased biotin threshold will assist with removing the biotin distraction for our customers while enabling continuous workflow efficiency. For our patients, they will no longer need to wait for an 8-hour timeframe to have their blood drawn. We look forward to continuously providing this immunoassay improvement within our portfolio of products as FDA approval permits.
All laboratory testing is susceptible to interference — and it always has been. There are numerous potential interferences affecting assays from all manufacturers. And while the exact frequency of interference from all sources in unknown, testing according to package inserts will mitigate the risk.
Roche monitors incidences of interferences, which include quantitative monitoring and making decisions about necessary action.
Education around common lab interferences is critical. Below is a non-exhaustive list of over 10 common lab test interferences. Additionally, please refer to the method sheets for your immunoassay solutions for more information on these potential interferences.
Hormone Binding Proteins
HAMA (other Human anti-animal antibodies)
Autoantibodies
High-dose Hook Effect
Paraproteins
Therapeutic Antibodies
Hemolysis
Lipemia
Bilirubin
Rheumatoid Factor
Pharmaceuticals
Biotin
Over the past few years, the promotion of high concentration biotin supplements promoting hair, skin, and nail health have created changes in consumer consumption while lacking clinical evidence on the efficacy of these over the counter products.
As all laboratory testing is susceptible to interferences, biotin is one of the many supplements with the potential to interfere with results. We understand this has created a distraction for your lab and the educational materials provided will continue to put the potential for biotin interference into proper context.
You and the physicians you support have always relied on Roche assays as an important part of the full clinical picture. This is why education remains a best practice toward mitigating risk of interference. In an effort to continue to partner with you and leverage your expertise in laboratory medicine, we remain committed to providing you with information and resources to reinforce education related to biotin and other interferences.
We recommend that you leverage this information and have ongoing dialogue with the healthcare professionals you support to help ensure they continue to know the right questions to ask and why it’s important to encourage patients to report all prescriptions and over-the-counter medications, including supplements.
* Opinion Research Corporation Survey December 2017 commissioned by Roche Diagnostics.
In this example, biotin is ingested before the typical patient arrives at the ED (studies indicate patients go to the ED within about 3.5-64 hours after symptoms begin). If testing is performed according to the guidelines (baseline and 3-6 hours) biotin levels will have significantly decreased by the 3 hour time point and not mask the rise in troponin. Also between the baseline and 3 hour time points (where the Negative Predictive Value (NPV) of Troponin T Gen 5 is 99.7%,) the troponin kinetics will show arise above the 99th percentile represented by the heart symbol.
So a quick elimination of the biotin and serial testing mitigates risk.
Educational fact sheet for physicians about biotin that includes questions to ask patients
Slide presentation for clinical partners to provide education on biotin interference and best practices to mitigate risk
Printable PDF with pre-testing information given to patients in advance of blood draws
Posters to help build awareness about reporting all OTC, supplement and RX use
Providing education around Roche assays and potential biotin interference, as well as best practice sharing for your institution.
Dr. Ursula Klause, Roche Diagnostics
Dr. Nam Tran, UC Davis
