- Companies manufacturing in vitro diagnostic tests and devices that use biotin technology should include the impact of high levels of vitamin B7 intake on the labeling of such devices due to the potential for incorrect results from biotin interference, FDA said in a draft guidance published Thursday.
- It follows a November 2017 safety warning that biotin, also known as vitamin B7, has the potential to "significantly interfere with certain lab tests and cause incorrect test results which may go undetected." High levels of biotin in patient samples has the potential to cause false high or low test results depending on the diagnostic, FDA warned.
- Historically, FDA said devices using biotin technology have been tested for interference at typical daily doses of vitamin B7, but consumer use of dietary supplements and physician recommendations for high doses to treat conditions such as multiple sclerosis have resulted in much higher plasma/serum biotin levels in some patients.
Companies sponsoring a device moving through FDA should now test for biotin concentration levels up to 3500 ng/mL to account for current consumption of vitamin B7 by consumers. They should include analyte levels near medical decision points and list the concentration level where no interference is detected on labeling for assays susceptible to biotin interference.
The agency also is recommending that manufacturers currently marketing devices adhere to the draft recommendations.
"Information on biotin interference should be included in the labeling of the device, including the percent difference or bias at each concentration tested for both qualitative and quantitative assays and the consequence of biotin interference (e.g., falsely elevated, falsely depressed), if observed," the draft guidance stated.
Manufacturers should also adhere to Clinical Laboratory Standards Institute recommendations on interference testing, according to FDA.
Biotin technology is used in many hormone and heart health tests due to its ability to bind with specific proteins such as troponin.
In the 2017 safety communication, FDA said it received a report of a patient dying after high levels of biotin interference resulted in falsely low troponin test results. Troponin tests are often used to detect heart attacks.
In the draft guidance, FDA warns that new labeling practices will not single-handedly address the risk for high levels of vitamin B7 interfering with devices.
"These recommendations should not be interpreted to mean that FDA considers that labeling alone will be sufficient to mitigate the risk of incorrect results from biotin interference in all cases," the draft guidance said.
FDA is collecting comments on the draft guidance for 60 days.