Biotin Alert – Potential assay interference

Potential Assay Interference – Biochemistry Immunoassay Tests

The immunoassay methods used in the Biochemistry laboratory at Exeter Blood Sciences use a streptavidin-biotin system in their design. If patients are taking large doses of Biotin (Vitamin B7), there is potential for interference in immunoassays analysed within Biochemistry.

Biotin is a water soluble B vitamin, with a recommended daily intake of 50 μg/day (UK guidance). This should be easily attainable, as it is widely available in food, and the vitamin may also be produced by bacteria in the intestine.

The use of large doses of Biotin as a health supplement for a variety of issues has recently been promoted in the popular press. Its use may therefore pass unnoticed or be disregarded by patients when they are asked about over the counter medication/supplements which they may be taking. These supplements from health food shops, or obtained online, may contain Biotin concentrations of up to 10,000 μg per tablet. The tests highlighted in bold below may be somewhat affected by these supplements.

Clinical trials of supraphysiological doses of Biotin (up to 300,000 μg/day) are currently underway in patients who have been diagnosed with multiple sclerosis and other neurodegenerative disorders. Patients with metabolic disturbances may also be prescribed with high dose Biotin. All immunoassays analysed at Exeter Blood Sciences may be significantly affected at these concentrations.

Interference is not anticipated in patients not taking these high dose supplements.

If you have a test result which does not fit the clinical picture, you may wish to exclude possible Biotin interference as a cause, by asking the patient/parent/carer about any supplements they may have taken or check for a prescription. No commercial assay is available to measure the concentration of Biotin in blood samples.

Particular care should be taken in interpreting Troponin levels, where Negative interference has been reported.

Biotin is renally excreted, with a half-life of approximately 2 hours in low doses. The manufacturers of the methods used in the Biochemistry laboratory advise that samples should not be taken from patients receiving therapy with high biotin doses (>5,000 μg/day) until at least 8 hours after the last biotin administration.

Elimination of supraphysiological doses (>100,000 μg/day) is thought to take up to 7 days.

However, this information relies on a number of factors, including the renal status of the patient. Biotin levels in patients with CKD/AKI may be higher as a result.

Reference:

Jenkins Colon, P, Greene, D.N. Biotin Interference in Clinical Immunoassays. J Appl Lab Med (2018) DOI: 10.1373/jalm.2017.024257

This table indicates the levels of Biotin above which the assay may be affected.

The concentration of Biotin in the blood of a person not taking supplements is <1 nmol/L

 

Assay name Biotin (nmol/L) Biotin Effect Positive/Negative
AFP 246 Negative
CA 125 143 Negative
CEA 491 Negative
Ferritin 205 Negative
FSH 246 Negative
hCG 327 Negative
LH 205 Negative
NT-pro BNP 123 Negative
Prolactin 164 Negative
PTH 205 Negative
SHBG 246 Negative
total PSA 246 Negative
Troponin T hs 82 Negative
TSH 102 Negative
Anti-TPO 40.9 Positive
Cortisol 123 Positive
Digoxin 409 Positive
Estradiol 147 Positive
Folate 86.1 Positive
FT3 286 Positive
FT4 81.8 Positive
Progesterone 123 Positive
Testosterone 123 Positive
Vitamin B12 246 Positive
Vitamin D 123 Positive

 

Posted 7 months ago on