Biotin (Vitamin B7) safety communication by the FDA – follow up

This communication represents a follow-up from our Scientific Update #277, published on 13-Dec-2017, in which ICON Laboratory Services (ILS) highlighted to our sponsors a safety communication released by the FDA on 28-Nov-17. As per the FDA notification: “The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Biotin levels higher than the recommended daily allowance may cause interference with lab tests.”1

Please be assured that ILS is addressing the FDA notification in a manner that is consistent with our commitment to results quality. At this time, ILS encourages healthcare providers to interpret associated clinical results for patients that are taking high levels of biotin with caution.

The ICON Laboratory Operations, Scientific and Medical groups are in receipt of further information from our vendors. The table below shows the current list of assays confirmed to contain biotin by the manufacturers.

As you would expect, the extent of biotin interference varies per assay and per subject depending on dosage level and frequency of ingestion. Ultimately the most appropriate action is to have subjects, whose specimens will be tested via at risk assays, abstain from ingesting biotin until it has had a chance to wash out of the system. The following publication suggests a wash out period of 8-73 hours depending on assay and dosage https://www.future-science.com/doi/pdf/10.4155/ipk-2017-00132

The extent of biotin interference varies per testing platform. ILS is committed to address this potential interference, where possible, via use of alternate assays which have proven no interference.   

Please contact your Project Manager to address further questions that you may have.

Immunoassay Tests with Potential Interference by Biotin Supplementation

Note: This list depends on assay method/platform. Assays marked with * exhibit ≤10% interference at a Biotin concentration of 1500 ng/mL. Tests codes marked with ** have already been replaced with an alternate solution that is not subject to interference from biotin and which has been utilised as standard by ICON since approximately 2015.

Assay

ILS Test Code

Assay

ILS Test Code

Adrenocorticotropic hormone  (ACTH)*

ACTH

Human Chorionic Gonadotropin  (beta-hCG)*

HCGQN**

Alpha-Fetoprotein*

AFP**

IFN-Gamma

IFNGAMMAMP

CA19-9

CA199

Insulin*

INS**

Calcitonin*

CALCITONIN

Interleukin-1 Beta

IL1BETAMP

Cortisol*

CORTAM, CORTPM**

Interleukin-10

IL10MP

Cotinine, Serum

SCOT

Interleukin-13

IL13MP

Cotinine, Ur., Quant.

UCOTQNT

Interleukin-2

IL2MP

EBV VCA IgG

EBVIGG

Interleukin-5

IL5MP

EBV VCA IgM

EBVIGM

Interleukin-6

IL6MP

Estradiol*

E2**

Interleukin-8

IL8MP

Ferritin*

FERR**

Luteinizing Hormone (LH)*

LH**

Folate

FOLATE**

Macrophage Inflammatory Protein - 1 beta

MIP1BETAMP

Follicle-stimulating hormone (FSH)*

FSH**

N Terminal ProBNP (NT proBNP)

PROBNP

Free T3*

FT3**

Prolactin*

PROL**

Free T4*

FT4**

Thyroid Stimulating Hormone (TSH)*

TSH**

GM-CSF

GMCSFMP

Thyroxine (T4)*

THYROXT4**

Hepatitis A antibody Total (HAVT)

HAVT

TNF- alpha

TNFALPHAMP

Hepatitis A IgM Antibody (HAV IgM)

HAVIGM

Total T3*

T3**

Hepatitis B Core IgM Antibody (HBc IgM Ab)

HBCOREABM

Troponin I

TROPIECLIA

Hepatitis Be Antibody

HEPBEAB

Troponin T

TROPT

Hepatitis Be Antigen

HEPBEAG

Vitamin B12

B12**

Homocysteine*

HOMOCYS**

 

 

Scientific Update Revision History

Version #

Publication Date

Comments

1

04-MAY-2018

Original Document

2

05-JUN-2018

Reference 4 added