ARUP’s Commitment

On November 28, 2017, the FDA issued a Safety Communication warning that “Biotin May Interfere with Lab Tests.”

ARUP sent an announcement to clients regarding the original FDA Safety Communication warning on December 6, 2017. ARUP has also identified the tests that can potentially be affected by high levels of biotin.

On November 5, 2019, the FDA issued an updated Safety Communication “Update: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication.”

Please be assured that ARUP responds to FDA notifications in a manner that is consistent with our commitment to quality and patient care.  ARUP continues to encourage health care providers to interpret associated clinical results for patients that are taking high levels of biotin with caution.

For additional questions, please contact ARUP Client Services, (800) 522-2787, and refer to the key word: Biotin Interference.

About Biotin

Biotin (vitamin B7) is a water-soluble B vitamin that helps turn carbs, fats, and proteins into energy. The recommended daily intake (RDI) varies based on age (adults: 30 µg/day). Biotin can be found in various foods, as well as multivitamins, prenatal vitamins, and dietary supplements.2 However, dietary supplements marketed for hair, skin, and nail growth may contain biotin concentrations up to 650 times (5–10 mg) the RDI. High dose supplementation of biotin (>10 mg/day) may be recommended for patients with certain inherited metabolic deficiencies/diseases or conditions such as multiple sclerosis (MS).1,3

Potential Effect(s) on Testing

While standard intake levels of biotin do not typically cause interference, higher levels may cause significant interference with certain immunoassays that use biotin-streptavidin technology and affect corresponding test results.1,3 This interference can cause false highs and false lows, potentially leading to misdiagnosis.

Patients may be unaware they are taking higher-than-recommended levels of biotin, so it is important for physicians to be diligent in obtaining a full list of supplements for testing accuracy. This information should then be communicated with the lab(s) conducting the test(s). For suspicious or inconsistent patient results, biotin interference may be considered. Consult with testing laboratory to discuss potential impact.1

Additional Resources

References

 
  1. FDA (Biotin) Safety Communication 2019.
  2. National Institutes of Health. Biotin fact sheet for consumers.
  3. Roche Diagnostics. Biotin facts.

Test List

Last updated: March 2020

User's Guide Name Test Mnemonic Test Order Number Threshold
ACTH by Immunohistochemistry ACTH IHC 2003427  
Adiponectin ADIP 70262  
Adrenocorticotropic Hormone ACTH 70010 Biotin up to 60ng/mL
Adrenocorticotropic Hormone Stimulation, 30 Minutes CORTISOL30 70032  
Adrenocorticotropic Hormone, IVC1 ACTH IVC1 70279 Biotin up to 60ng/mL
Adrenocorticotropic Hormone, LP1 ACTH LP1 70300 Biotin up to 60ng/mL
Adrenocorticotropic Hormone, RP1 ACTH RP1 70311 Biotin up to 60ng/mL
Aldosterone/Renin Activity Ratio A/RA 70073  
Alpha-1-Antichymotrypsin (A1ACT) by Immunohistochemistry A1 ACT IHC 2003418  
Alpha-1-Antitrypsin (AAT) by Immunohistochemistry A1 AT IHC 2003424  
Alpha-1-Fetoprotein (AFP) by Immunohistochemistry AFP IHC 2003436  
Amphiphysin Antibody, IgG AMPHIPHYS 2008893  
Anti-Human Epithelial Antigen, Ber-EP4 by Immunohistochemistry BEREP4 IHC 2003463  
Anti-Mullerian Hormone AMH 2002656  
Aquaporin-4 Receptor Antibody AQP4 2003036  
Aquaporin-4 Receptor Antibody by ELISA with Reflex to Aquaporin-4 Receptor Antibody, IgG by IFA AQP4 R 2013327  
Autoimmune Encephalitis Reflexive Panel AUTOENCEPH 2013601  
Autoimmune Liver Assessment w/ Reflx AUTO LIVER 2010850  
Autoimmune Neurologic Disease Reflexive Panel NEURO R 2013944  
Autoimmune Neuromuscular Junction Reflexive Panel MUWA R PAN 2005640  
Beta-hCG, Quantitative (Tumor Marker) BHCG TM 70029 Biotin up to 80ng/mL
Beta-hCG, Quantitative (Tumor Marker), CSF BHCG CSF 20730 Biotin up to 80ng/mL
Breast 2 (GCDFP-15) by Immunohistochemistry BRST2 IHC 2003472  
Breast Carcinoma b72.3 by Immunohistochemistry B72.3 IHC 2003445  
C1-Esterase Inhibitor Functional C1 INH F 50141  
C-1-Esterase Inhibitor Panel C1 INH PAN 50139  
C4D by Immunohistochemistry C4D IHC 2003475  
Cancer Antigen 125 CA125 80462 Biotin up to 35ng/mL
Cancer Antigen-Breast (CA 15-3) CA-BREAST 80464 Biotin up to 100ng/mL
Cancer Antigen-GI (CA 19-9) CA-GI 80461 Biotin up to 100ng/mL
Cancer Antigen-GI (CA 19-9), Body Fluid CA-GI FL 20746 Biotin up to 100ng/mL
Carcinoembryonic Antigen CEA 80080 Biotin up to 100ng/mL
Carcinoembryonic Antigen, Fluid CEA FL 20742 Biotin up to 100ng/mL
Carcinoembryonic Antigen, Polyclonal (CEA P) by Immunohistochemistry CEA P IHC 2003827  
CD123 by Immunohistochemistry CD123 IHC 2003809  
CD1a by Immunohistochemistry CD1A IHC 2003502  
CD21 (Dendritic Cell) by Immunohistochemistry CD21 IHC 2003535  
CD23 by Immunohistochemistry CD23 IHC 2003541  
CD31 by Immunohistochemistry CD31 IHC 2003550  
CD34, QBEnd/10 by Immunohistochemistry CD34 IHC 2003556  
CD35 by Immunohistochemistry CD35 IHC 2003559  
CD4 by Immunohistochemistry CD4 IHC 2003511  
CD42b by Immunohistochemistry (Temporary Referral as of 08/22/2017) CD42b IHC 2003565  
CD43, L60 (Leu 22) by Immunohistochemistry CD43 IHC 2003568  
CD61 (Platelet Glycoprotein IIIA) by Immunohistochemistry CD61 IHC 2003595  
CD79A by Immunohistochemistry CD79A IHC 2003800  
Collagen IV by Immunohistochemistry COLL 4 IHC 2003839  
Cotinine Screen, Urine COTININE 2007081 No biotin interference studied
C-Telopeptide, Beta-Cross-Linked, Serum CTX 70416  
CYFRA 21-1 (Cytokeratin 19 Fragment), Serum CYFRA 81344  
Cytokeratin 20 (CK 20) by Immunohistochemistry CYTO20 IHC 2003848  
Cytokeratin 8,18 Low Molecular Weight (CAM 5.2) by Immunohistochemistry CAM5.2 IHC 2003493  
Cytokine Panel CYT 12 SE 51394  
Cytokine Panel, Monokines CYT MON SE 51524  
Cytokine Panel, TH1 CYT TH1 SE 51408  
Cytokine Panel, TH2 CYT TH2 SE 51518  
Cytokine Production by Mononuclear Cells in Response to Antigen and Mitogen Stimulation CYT AM 2013111  
Dehydroepiandrosterone Sulfate, Serum DHEAS 70040 Biotin up to 30ng/mL
E-Cadherin by Immunohistochemistry ECADH IHC 2003869  
Epithelial Membrane Antigen (EMA) by Immunohistochemistry EMA IHC 2003872  
Epstein-Barr Virus (EBV) by in situ Hybridization, Paraffin EBV ISH 2002902  
Estrogen Receptor (ER) by Immunohistochemistry ER IHC 2004516  
Ewing Sarcoma (O13) by Immunohistochemistry O13 IHC 2004055  
Fetal Fibronectin FFN 82024  
Fibrillarin (U3 RNP) Antibody, IgG U3 FIB 2012173  
FIBRINOGEN by IF Technical Only (Bill Only, for Internal Use Only) FIBR IFT 2005397  
Follicle Stimulating Hormone, Serum FSH 70055 Biotin up to 60ng/mL
Gastrin GAST 70075 Biotin above 2ng/mL
Gastrin by Immunohistochemistry GASTRI IHC 2003896
Gastrin, 1 Minute GAST 1 2012636 Biotin above 2ng/mL
Gastrin, 10 Minute GAST 10 2012734 Biotin above 2ng/mL
Gastrin, 2 Minute GAST 2 2012638 Biotin above 2ng/mL
Gastrin, 30 Minute GAST 30 2012736 Biotin above 2ng/mL
Gastrin, 5 Minute GAST 5 2012732 Biotin above 2ng/mL
Gastrin, Baseline GAST BASE 2012738 Biotin above 2ng/mL
Glial Fibrillary Acidic Protein (GFAP) by Immunohistochemistry GFAP IHC 2003899  
Glutamic Acid Decarboxylase Antibody GAD-AB 2001771  
Glycophorin A by Immunohistochemistry GLYC A IHC 2003908  
Granzyme B by Immunohistochemistry GRANZB IHC 2007173  
Hairy Cell Leukemia, DBA.44 by Immunohistochemistry DBA 44 IHC 2003860  
Hepatitis A Virus Antibodies (Total) HAVAB 20591  
Hepatitis A Virus Antibody, IgM HAVABM 20093  
Hepatitis A Virus Panel HEP A PAN 20597  
Hepatitis B Virus (HBV) Perinatal Exposure Follow-up by CIA, Panel HBV PAN PN 2014285  
Hepatitis B Virus Core Antibodies (Total) HBCAB 20091  
Hepatitis B Virus Core Antibody, IgM HBCABM 20092  
Hepatitis B Virus Panel, Chronic with Reflex to HBsAg Confirmation HEPCHRONIC 20454  
Hepatitis B Virus Surface Antibody HBSAB 20090  
Hepatitis B Virus Surface Antigen Confirmation, Prenatal HBSAGCONPN 2007575  
Hepatitis B Virus Surface Antigen with Reflex to Confirmation HBSAG 20089  
Hepatitis B Virus Surface Antigen with Reflex to Confirmation, Prenatal HBSAG PN 2007573  
Hepatitis B Virus Surface Antigen, Confirmation HBSAG CONF 20128  
Hepatitis C Virus Antibody by CIA HCV AB 2002483  
Hepatitis C Virus Antibody by CIA with Reflex to HCV by Quantitative PCR HCV AB QR 2010784  
Hepatitis Panel, Acute with Reflex to HBsAg Confirmation HEP ACUTE 20457  
Hepatocyte Specific Antigen (HSA) by Immunohistochemistry HEP SA IHC 2003923  
Histoplasma Antigen by EIA, Serum HISTOAG S 92522  
Histoplasma Galactomannan Antigen Quantitative by EIA, Urine HISTOGM U 2009418  
Human Chorionic Gonadotropin (Beta-hCG) by Immunohistochemistry HCG IHC 2003920  
Human Epididymis Protein 4 (HE4) HE4 2003020 Biotin up to 50ng/mL
Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA with Reflex to HIV-1/HIV-2 Antibody Differentiation, Supplemental HIVAGABGE 2013333  
Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA, Reflexive Panel HIV PANEL 2012674  
Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2) by CIA, with Reflex to HIV-1 Antibody Confirmation by Western Blot HIV AGAB 2006526  
Human Immunodeficiency Virus Type 1 (HIV-1) Antibody by CIA with Reflex to HIV-1 Antibody Confirmation by Western Blot HIV 1 SCRN 2005375  
Human Immunodeficiency Virus Types 1 and 2 (HIV-1, HIV-2) Antibodies by CIA with Reflex to HIV-1 Antibody Confirmation by Western Blot HIV1,2 SCR 2005377  
Human Papillomavirus (HPV) Low Risk by in situ Hybridization, Paraffin HPVLOW ISH 2002896  
Human Papillomavirus (HPV), High Risk by in situ Hybridization, Paraffin HPVHI ISH 2002899  
Human Placental Lactogen (HPL) by Immunohistochemistry HPL IHC 2003938  
Immunoglobulin A (IgA) by Immunohistochemistry IGA IHC 2003957  
Immunoglobulin D (IgD) by Immunohistochemistry IGD IHC 2003960  
Immunoglobulin M (IgM) by Immunohistochemistry IGM IHC 2003966  
Influenza A Virus H1/H3 Subtype by PCR with Reflex to H1N1 (2009) Oseltamivir Resistance by Sequencing FLUTYPE RE 2008788  
Inhibin B INHIBINB 70413  
Inhibin by Immunohistochemistry INHIBI IHC 2003969  
Interferon gamma IFNG DO 51531  
Interleukin 1 beta IL1B DO 51536  
Interleukin 10 IL10 DO 51534  
Interleukin 12 IL12 DO 51530  
Interleukin 13 IL13 DO 51535  
Interleukin 17 IL17 2013115  
Interleukin 2 IL2 DO 51588  
Interleukin 2 Receptor (CD25), Soluble IL2R DO 51529  
Interleukin 4 IL4 DO 51532  
Interleukin 5 IL5 DO 51533  
Interleukin 6 IL6 DO 51537  
Interleukin 8 IL8 DO 51538  
Kappa Light Chains by Immunohistochemistry KAPPA IHC 2003981  
Kappa/Lambda Light Chain Panel by in situ Hybridization, Paraffin K/L ISH 2002888  
Keratin 903 (K903) High Molecular Weight by Immunohistochemistry K903 IHC 2003978  
Ki-67, MIB-1, by Immunohistochemistry MIB1 IHC 2004519  
Lambda Light Chains by Immunohistochemistry LAMBDA IHC 2003984  
Liver Cytosolic Antigen Type 1 (LC-1) Antibody, IgG LC-1 2010711  
Luteinizing Hormone and Follicle Stimulating Hormone LH/FSH 70193 Biotin up to 50ng/mL and 60ng/mL, respectively
Luteinizing Hormone, Serum LH 70093 Biotin up to 50ng/mL
Lysozyme (Muramidase) by Immunohistochemistry LYSOZY IHC 2003990  
Mannose Binding Lectin MBL 51692  
Mast Cell Tryptase by Immunohistochemistry MASTCT IHC 2003993  
Muscle-Specific Actin (MSA) by Immunohistochemistry MUSA IHC 2004011  
Myelin Basic Protein MBP 80515  
Myeloperoxidase (MPO) by Immunohistochemistry MYELOP IHC 2004014  
Myoglobin by Immunohistochemistry MYOGL IHC 2004031  
Myoglobin, Serum MYOG-S 20224 Biotin up to 50ng/mL
Myoglobin, Urine MYOG-U 20223  
Myosin by Immunohistochemistry MYOSIN IHC 2004034  
Neurofilament by Immunohistochemistry NEUROF IHC 2004049  
Neuron Specific Enolase NSE 98198  
Neuron Specific Enolase, CSF NSE CSF 81226  
Neuron Specific Enolase, Polyclonal (NSE P) by Immunohistochemistry NSE IHC 2004052  
Neuronal Abs (Hu, Ri, Yo, Amphiphysin) NEURONAL 51090  
Neuronal Nuclei (NeuN) by Immunohistochemistry NEUN IHC 2004046  
New York Human Immunodeficiency Virus (HIV) Combo Antigen/Antibody (HIV-1/O/2), Reflexive Panel NY HIV PAN 2014211  
Osteocalcin by Electrochemiluminescent Immunoassay OSTEO NMID 20728  
p21 (Waf1/Cip 1) by Immunohistochemistry P21 IHC 2004067  
p53 by Immunohistochemistry P53 IHC 2004522  
Pan Cytokeratin (AE1,3) by Immunohistochemistry AE1,3 IHC 2003433  
Pancreatic Elastase, Fecal by ELISA PAN-ELAST 80526  
Paraneoplastic Reflexive Panel PNS PAN 2013955  
Parathyroid Hormone, Fine Needle Aspiration (FNA) PTH FNA 2001491 Biotin up to 50ng/mL
Parathyroid Hormone, Intact PTH-INT 70346 Biotin up to 50ng/mL
Parathyroid Hormone, Intact with Calcium PTHI 70172 Biotin up to 50ng/mL
PAX8 by Immunohistochemistry PAX8 IHC 2010787  
PD-1 by Immunohistochemistry PD1 IHC 2004085  
Placental Alkaline Phosphatase (PLAP) by Immunohistochemistry PLAP IHC 2004097  
PM/Scl-100 Antibody, IgG by Immunoblot PM/SCL 2003040  
Prenatal Reflexive Panel PRENATAL A 95044  
proBrain Natriuretic Peptide, NT PRO BNP 50083  
Progesterone Receptor (PR) by Immunohistochemistry PR IHC 2004525  
Prolactin by Immunohistochemistry PROLAC IHC 2004109  
Prostate Specific Antigen, Free Percentage (Includes Free PSA and Total PSA) PSA FP 80206 Biotin up to 30ng/mL and 60ng/mL, respectively
Prostate Specific Antigen, Total PSA 70121 Biotin up to 60ng/mL
Prostate Specific Antigen, Total - Medicare Screening PSA SCN 70234 Biotin up to 60ng/mL
Prostate Specific Antigen, Total with Reflex to Free PSA (Includes Free Percentage) TPSAR 80264 Biotin up to 30ng/mL and 60ng/mL, respectively
Prostate Specific Antigen, Ultrasensitive PSA ULTRA 98581  
Prostatic Acid Phosphatase (PAP) by Immunohistochemistry PAP IHC 2004079  
Reflexed to Free PSA (Includes Free Percentage) BILL PSAFR 50338 Biotin up to 60ng/mL and 30ng/mL, respectively
Renin Activity RENIN 70105  
Risk of Ovarian Malignancy Algorithm ROMA 2012618 Biotin up to 50ng/mL
S-100B Protein, Serum S 100B 2001766  
Sex Hormone Binding Globulin SHBG 99375 Biotin up to 60ng/mL
Smooth Muscle Actin (SMA) by Immunohistochemistry SMA IHC 2004130  
Squamous Cell Carcinoma Antigen, Serum SCC 81054  
ST2, Soluble ST2 2002270  
Surgical Pathology Tissue SP REQUEST 8090010  
Systemic Sclerosis Comprehensive Panel SCL COMP 2013325  
T3 Uptake T3 UP 70135 Biotin up to 40ng/mL
T-cell Intracytoplasmic Antigen (TIA-1) by Immunohistochemistry TIA1 IHC 2004148  
TdT by Immunohistochemistry TDT IHC 2004142  
Testosterone Free, Adult Male FREE T2 70111 Biotin up to 30ng/mL
Testosterone, Adult Male TESTOS 70130 Biotin up to 30ng/mL
Testosterone, Bioavailable and Sex Hormone Binding Globulin (Includes Total Testosterone), Adult Male BIO T 70102 Biotin up to 30ng/mL
Testosterone, Bioavailable and Sex Hormone Binding Globulin (Includes Total Testosterone), Females or Children BIO T MASS 81057 Biotin up to 30ng/mL
Testosterone, Free and Total (Includes Sex Hormone Binding Globulin), Adult Male FREE T 70109 Biotin up to 30ng/mL
Testosterone, Free and Total (Includes Sex Hormone Binding Globulin), Females or Children TESTOS F&T 81056 Biotin up to 30ng/mL
Thyroglobulin Antibody ATHYG 50105  
Thyroglobulin, Serum or Plasma with Reflex to LC-MS/MS or CIA THYROGRFX 2006685  
Thyroid Antibodies THYRO 50645  
Thyroid Peroxidase (TPO) Antibody AMICR 50075  
Thyroid Stimulating Hormone TSH 70145  
Thyroid Stimulating Hormone Receptor Antibody (TRAb) TR AB 2002734  
Thyroid Transcription Factor (TTF-1) by Immunohistochemistry TTF1 IHC 2004166  
Thyroxine T4 70140  
Thyroxine, Free (Free T4) FT4 70138  
Toll-Like Receptor Function TLR 51589  
Toxoplasma gondii by Immunohistochemistry (Temporary Referral as of 08/22/2017) TOXOPL IHC 2004157  
Transforming Growth Factor beta, Plasma TGFB PLA 51690  
Transforming Growth Factor beta, Serum TGFB SER 51694  
Triiodothyronine, Free (Free T3) FT3 70133  
Triiodothyronine, Total (Total T3) T3 TOTAL 70474  
Tumor Necrosis Factor - alpha TNFA DO 51539  
Vitamin D, 1, 25-Dihydroxy VIT D 1,25 80385 Biotin up to 0.1mg/dL
Zinc Transporter 8 Antibody ZNT8 AB 2006196