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
ACTH by Immunohistochemistry ACTH IHC 2003427
Adrenocorticotropic Hormone ACTH 70010
Adrenocorticotropic Hormone Stimulation, 30 Minutes CORTISOL30 70032
Adrenocorticotropic Hormone, IVC1 ACTH IVC1 70279
Adrenocorticotropic Hormone, LP1 ACTH LP1 70300
Adrenocorticotropic Hormone, RP1 ACTH RP1 70311
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
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 Liver Assessment w/ Reflx AUTO LIVER 2010850
Autoimmune Neuromuscular Junction Reflexive Panel MUWA R PAN 2005640
Beta-hCG, Quantitative (Tumor Marker) BHCG TM 70029
Beta-hCG, Quantitative (Tumor Marker), CSF BHCG CSF 20730
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
Cancer Antigen-Breast (CA 15-3) CA-BREAST 80464
Cancer Antigen-GI (CA 19-9) CA-GI 80461
Cancer Antigen-GI (CA 19-9), Body Fluid CA-GI FL 20746
Carcinoembryonic Antigen CEA 80080
Carcinoembryonic Antigen, Fluid CEA FL 20742
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
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
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
Gastrin GAST 70075
Gastrin by Immunohistochemistry GASTRI IHC 2003896
Gastrin, 1 Minute GAST 1 2012636
Gastrin, 10 Minute GAST 10 2012734
Gastrin, 2 Minute GAST 2 2012638
Gastrin, 30 Minute GAST 30 2012736
Gastrin, 5 Minute GAST 5 2012732
Gastrin, Baseline GAST BASE 2012738
Glial Fibrillary Acidic Protein (GFAP) by Immunohistochemistry GFAP IHC 2003899
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
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 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
Luteinizing Hormone, Serum LH 70093
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
Myeloperoxidase (MPO) by Immunohistochemistry MYELOP IHC 2004014
Myoglobin by Immunohistochemistry MYOGL IHC 2004031
Myoglobin, Serum MYOG-S 20224
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
Parathyroid Hormone, Intact PTH-INT 70346
Parathyroid Hormone, Intact with Calcium PTHI 70172
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
Prostate Specific Antigen, Total PSA 70121
Prostate Specific Antigen, Total - Medicare Screening PSA SCN 70234
Prostate Specific Antigen, Total with Reflex to Free PSA (Includes Free Percentage) TPSAR 80264
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
Risk of Ovarian Malignancy Algorithm ROMA 2012618
S100B CSF S100B CSF 2013358
S-100B Protein, Serum S 100B 2001766
Sex Hormone Binding Globulin SHBG 99375
Smooth Muscle Actin (SMA) by Immunohistochemistry SMA IHC 2004130
Surgical Pathology Tissue SP REQUEST 8090010
Systemic Sclerosis Comprehensive Panel SCL COMP 2013325
T3 Uptake T3 UP 70135
T-cell Intracytoplasmic Antigen (TIA-1) by Immunohistochemistry TIA1 IHC 2004148
TdT by Immunohistochemistry TDT IHC 2004142
Testosterone Free, Adult Male FREE T2 70111
Testosterone, Adult Male TESTOS 70130
Testosterone, Bioavailable and Sex Hormone Binding Globulin (Includes Total Testosterone), Adult Male BIO T 70102
Testosterone, Free and Total (Includes Sex Hormone Binding Globulin), Adult Male FREE T 70109
Thyroglobulin Antibody ATHYG 50105
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
Troponin T (cTnT) 5th Generation CTNT 3001831
Tumor Necrosis Factor - alpha TNFA DO 51539
Vitamin D, 1, 25-Dihydroxy VIT D 1,25 80385