Readers respond: Strategies for combatting biotin interference

July 25, 2017

Dear MLO Editor:

The article entitled, “Strategies for combatting biotin interference” by Lori Lai (MLO. 2017;49(7):22-24) in the July 2017 issue reviewed the potential risk of interference in lab testing due to biotin. This supplement has become a focus of discussion in laboratories during the last year due, in large part, to the availability of high-concentration biotin supplements as over-the-counter lifestyle supplements promoting hair, skin, and nail health.

All laboratory testing is susceptible to interferences. This is not new. Biotin may be one interference among many others. New medications appear at a rapidly growing rate, while unregulated dietary supplements continue to saturate store shelves. Therefore, there is no question that practical strategies for mitigating interference should be in place in every institution, and these laboratory best practices can be translated to biotin and other known interference risks.

As the author recommends, one important strategy is close collaboration between the laboratory and clinical staff. In my view, however, the author’s suggestion that the only definitive mitigation strategy for biotin interference risk is use of biotin-free immunoassay platforms can not only lead to the loss of the myriad and life-saving benefits of laboratory
automation; it is also fundamentally impractical.

Our institution mined our electronic medical record (EMR) data to arrive at best practices to prevent biotin interference that were pragmatic, balancing efficacy, safety, and cost-effectiveness. Our solution is a three-part effort:

Education: This is the first line of defense. We believe the laboratory must be the leader in educating both providers and patients about biotin and other potential test interferences. This can be accomplished through lab representation at grand rounds, participating in clinician/staff meetings, and the establishment of multidisciplinary teams, partnerships, and multi-modality means, including use of social media, to disseminate knowledge and information.

Surveillance: At UC Davis, we established a surveillance program to determine the significance of biotin interference. This program builds on a decade-old institutional culture to evaluate potential interferences for in vitro diagnostics. For biotin, our studies support that the dose and timing are key. Based on our EMR data, at UC Davis, very few thyroid testing patients are dosing with high amounts of biotin. Furthermore, pilot interference studies have not observed any clinically significant interference for common biotinylated assays when compared against a non-biotinylated methodology among patients reportedly taking biotin. These data suggest that the dose is sufficiently low and/or patients are taking biotin long before or after laboratory testing—enabling sufficient time for the compound to clear (half-life: ~2 hours). In terms of biotinylated cardiac troponin assays, there are several details that work in the laboratory’s favor: a) Patients would rarely be taking biotin upon onset of ischemic symptoms; b) Patients often take several hours to decide to go to the hospital when suspecting a heart attack; and c) Serial testing requirements for troponins (for example, 0 and 3 hours), all of which provide time to eliminate any pre-existing biotin.

Electronic alert systems: By leveraging electronic solutions, a great deal of valuable information can be collected and used for decision-making. For example, electronic systems can send reminders to patients to refrain from taking biotin before their blood collection. Alternately, patients can self-report biotin use, which can be documented in the EMR system. Additionally, orders of susceptible tests could be flagged by providers and the laboratory. More intelligent systems may also take into account the known pharmacokinetics of biotin to ensure proper timing of affected results.

Ultimately, the question laboratories should ask themselves is: What lab test doesn’t come with interferences? Switching platforms to mitigate a single risk that may or not exist in your institution needs to be weighed against the benefits of automation, speed, and accuracy of the technology. Instead, there is far more immediate and long-term value in combatting potential interference risk, whether in the instance of biotin or another trendy supplement or vitamin, with leadership in education, surveillance, and communication.

—Nam K. Tran, PhD, FACB
Director of Chemistry, POCT, and SARC
Clinical and Quality Research, Dept. of Pathology and Lab Medicine, UC Davis

Dear Dr. Tran: Thank you for your valuable perspective on an important problem. I would be pleased to hear from other readers on the topic of the best ways for labs to proactively combat the problem of interference from biotin and other substances.—Editor

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