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
Adenovirus by Immunohistochemistry ADENOV 2003430
Adrenocorticotropic Hormone ACTH 70010
Adrenocorticotropic Hormone, IVC1 ACTH IVC1 70279
Adrenocorticotropic Hormone, LP1 ACTH LP1 70300
Adrenocorticotropic Hormone, RP1 ACTH RP1 70311
AE1,3 (Keratin) by Immunohistochemistry AE1,3 IHC 2003433
ALK1 by Immunohistochemistry ALK1 IHC 2003439
ALK (D5F3) with Interpretation by Immunohistochemistry ALKD5F3 IP 2007324
Alpha-1 AT by Immunohistochemistry A1 AT IHC 2003424
Alpha-1-Fetoprotein (AFP) by Immunohistochemistry AFP IHC 2003436
Alpha-Synuclein by Immunohistochemistry A-SYN IHC 2003419
Androgen Receptor by Immunohistochemistry AR IHC 3002791
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
Arginase 1 by Immunohistochemistry ARG1 IHC 2011890
ATRX by Immunohistochemistry ATRX IHC 2014499
BAf47/Ini-1 by Immunohistochemistry BAf47 IHC 2003448
BAP1 by Immunohistochemistry BAP1 IHC 3004244
Beta-hCG, Quantitative (Tumor Marker) BHCG TM 70029
Beta-hCG, Quantitative (Tumor Marker), CSF BHCG CSF 20730
BCL-2 by Immunohistochemistry BCL-2 IHC 2004513
BCL-6 (CD19) by Immunohistochemistry BCL-6 IHC 2003457
BCL10 by Immunohistochemistry BCL10 IHC 3003393
BER-EP4 by Immunohistochemistry BEREP4 IHC 2003463
Beta-Catenin 1 by Immunohistochemistry B-CAT1 IHC 2003454
BF-1 by Immunohistochemistry BF-1 IHC 2003466
BOB-1 by Immunohistochemistry BOB-1 IHC 2003442
Brachyury by Immunohistochemistry BRACHY IHC 3003824
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
CAIX (CA9) by Immunohistochemistry CAIX IHC 3001697
Calcitonin by Immunohistochemistry CALCIT IHC 2003481
Caldesmon by Immunohistochemistry CALDES IHC 2003484
Calponin by Immunohistochemistry CALPON IHC 2003487
Calretinin by Immunohistochemistry CALRET IHC 2003490
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
CD10 by Immunohistochemistry CD10 IHC 2003523
CD117, C-KIT by Immunohistochemistry CD117 IHC 2003806
CD123 by Immunohistochemistry CD123 IHC 2003809
CD138 by Immunohistochemistry CD138 IHC 2003812
CD14 by Immunohistochemistry CD14 IHC 2003526
CD15 by Immunohistochemistry CD15 IHC 2003529
CD163 by Immunohistochemistry CD163 IHC 2003815
CD19 by Immunohistochemistry CD19 IHC 2005114
CD1a by Immunohistochemistry CD1A IHC 2003502
CD2 by Immunohistochemistry CD2 IHC 2003505
CD20 by Immunohistochemistry CD20 IHC 2003532
CD200 by Immunohistochemistry CD200 IHC 2012844
CD21 (Dendritic Cell) by Immunohistochemistry CD21 IHC 2003535
CD23 by Immunohistochemistry CD23 IHC 2003541
CD25 by Immunohistochemistry CD25 IHC 2003544
CD3 by Immunohistochemistry CD3 IHC 2003508
CD30 by Immunohistochemistry CD30 IHC 2003547
CD31 by Immunohistochemistry CD31 IHC 2003550
CD33 by Immunohistochemistry CD33 IHC 2003553
CD34, QBEnd/10 by Immunohistochemistry CD34 IHC 2003556
CD35 by Immunohistochemistry CD35 IHC 2003559
CD4 by Immunohistochemistry CD4 IHC 2003511
CD43, L60 (Leu 22) by Immunohistochemistry CD43 IHC 2003568
CD45 by Immunohistochemistry CD45 IHC 2003574
CD5 by Immunohistochemistry CD5 IHC 2033514
CD52 by Immunohistochemistry CD52 IHC 2003586
CD56, NCAM by Immunohistochemistry CD56 IHC 2003589
CD61 (Platelet Glycoprotein IIIA) by Immunohistochemistry CD61 IHC 2003595
CD68 (Kp1) by Immunohistochemistry CD68 IHC 2003598
CD7 by Immunohistochemistry CD7 IHC 2003517
CD71 by Immunohistochemistry CD71 IHC 3003704
CD79A by Immunohistochemistry CD79A IHC 2003800
CD8 by Immunohistochemistry CD8 IHC 2003520
CDK4 by Immunohistochemistry CDK4 IHC 2005534
CDX2 by Immunohistochemistry CDX2 IHC 2003821
CEA Mono by Immunohistochemistry CEA M IHC 2003824
Chromogranin by Immunohistochemistry CHROMO IHC 2003830
Chymotrypsin by Immunohistochemistry CHYMO IHC 3003423
CMV by Immunohistochemistry CMV IHC 2003833
C-MYC by Immunohistochemistry CMYC IHC 2008317
Collagen IV by Immunohistochemistry COLL 4 IHC 2003839
Cotinine Screen, Urine COTININE 2007081
COVID-19 IgG (Spike), Semi-Quantitative by CIA COV19G SQ 3003648
C-Telopeptide, Beta-Cross-Linked, Serum CTX 70416
CXCL 13 by Immunohistochemistry CXCL13 IHC 2008622
Cyclin D1 SP4 by Immunohistochemistry CYCSP4 IHC 2003842
CYFRA 21-1 (Cytokeratin 19 Fragment), Serum CYFRA 81344
Cytokeratin 20 (CK 20) by Immunohistochemistry CYTO20 IHC 2003848
Cytokeratin 5/6 by Immunohistochemistry CYTO56 IHC 2003851
Cytokeratin 7 by Immunohistochemistry CYTO 7 IHC 2003854
Cytokeratin LMW (CAM 5.2) by Immunohistochemistry IHC CAM5.2 2003493
Cytokine Panel 13, CSF CYT13 CSF 3003259
Cytokine Panel 13, Serum CYT 12 SE 51394
Cytokine Panel 13, Plasma CYT13 PLA 3002601
Cytokine Panel, Monokines, Plasma CYT MON P 3002616
Cytokine Panel, Monokines, Serum CYT MON SE 51524
Cytokine Panel, TH, Serum CYT TH1 SE 51408
Cytokine Panel, TH1, Plasma CYT TH1 P 3002617
Cytokine Panel, TH1, Plasma CYT TH2 P 3002627
Cytokine Panel, TH2, Serum CYT TH2 SE 51518
D2-40 by Immunohistochemistry D2-40 IHC 2003857
DBA 44 (Hairy Cell) by Immunohistochemistry DBA 44 IHC 2003860
Dehydroepiandrosterone Sulfate, Serum DHEAS 70040
Desmin by Immunohistochemistry DESMIN IHC 2003863
DOG-1 by Immunohistochemistry DOG1 IHC 2010168
E-Cadherin by Immunohistochemistry ECADH IHC 2000708
Epithelial Membrane Antigen (EMA) by Immunohistochemistry EMA IHC 2000711
ERA (Moc-31) by Immunohistochemistry ERA IHC 2003875
ERG by Immunohistochemistry ERG IHC 2012555
Estrogen Receptor (ER) by Immunohistochemistry ER IHC 2004516
Ewing Sarcoma (O13) by Immunohistochemistry O13 IHC 2004055
Factor XIII by Immunohistochemistry FAC 13 IHC 2003878
Fetal Fibronectin FFN 82024
FIBRINOGEN by IF Technical Only (Bill Only, for Internal Use Only) FIBR IFT 2005397
Follicle Stimulating Hormone, Serum FSH 70055
FSH by Immunohistochemistry FSH IHC 2010166
Fumarate Hydratase by Immunohistochemistry FUMHYD IHC 3001416
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
GLUT-1 by Immunohistochemistry GLUT-1 IHC 2003905
Glycophorin A by Immunohistochemistry GLYC A IHC 2003908
Glypican 3 by Immunohistochemistry GLYP3 IHC 2011925
Granzyme B by Immunohistochemistry GRANZB IHC 2007173
H3K27M by Immunohistochemistry H3K27M IHC 3004370
H3K27me3 by Immunohistochemistry H3K27me3 IHC 3004364
Helicobacter pylori by Immunohistochemistry HPYLOR IHC 2003941
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 Panel, Chronic with Reflex to HBsAg Confirmation HEPCHRONIC 20454
Hepatitis B Virus Surface Antibody HBSAB 20090
Hepatitis B Virus Surface Antigen with Reflex to Confirmation HBSAG 20089
Hepatitis B Virus Surface Antigen with Reflex to Confirmation, Prenatal HBSAG PN 2007573
Hepatocyte Specific Antigen (HSA) by Immunohistochemistry HEP SA IHC 2003923
HercepTest (stain only) by Immunohistochemistry HERCEP IHC 2007332
Herpes Simplex Virus (HSV) Types I/II  Cocktail by Immunohistochemistry HSV IHC 3000101
HGAL by Immunohistochemistry HGAL IHC 3004201
HMB 45 (Melanoma Specific A) by Immunohistochemistry HMB 45 IHC 2003935
HMB45 RED by Immunohistochemistry HMB45R IHC 3003741
HNF-1 by Immunohistochemistry HNF1B IHC 3001791
Human Chorionic Gonadotropin (Beta-hCG) by Immunohistochemistry HCG IHC 2003920
Human Epididymis Protein 4 (HE4) HE4 2003020
Human Growth Hormone by Immunohistochemistry HGH IHC 2003929
HHV8 by Immunohistochemistry HHV8 IHC 2003932
Human Placental Lactogen (HPL) by Immunohistochemistry HPL IHC 2003938
IDH1 R132H Mutation by Immunohistochemistry IDH1 IHC 2005857
Immunoglobulin D (IgD) by Immunohistochemistry IGD IHC 2003960
Immunoglobulin G (IgG) by Immunohistochemistry IGG IHC 2003963
Immunoglobulin G4 (IgG4) by Immunohistochemistry IGG4 IHC 2005844
Inhibin by Immunohistochemistry INHIBI IHC 2003969
Interferon gamma, Plasma IFNG PLA 3002628
Interferon gamma, Serum IFNG DO 51531
Interleukin 1 beta, Plasma IL1B PLA 3002629
Interleukin 1 beta, Serum IL1B DO 51536
Interleukin 10, Plasma IL10 PLA 3002623
Interleukin 10, Serum IL10 DO 51534
Interleukin 12, Plasma IL12 PLA 3002624
Interleukin 12, Serum IL12 DO 51530
Interleukin 13, Plasma IL13 PLA 3002625
Interleukin 13, Serum IL13 DO 51535
Interleukin 17, Plasma IL17 PLA 3002626
Interleukin 17, Serum IL17 2013115
Interleukin 2, Plasma IL2 PLA 3002630
Interleukin 2, Serum IL2 DO 51588
Interleukin 2 Receptor, Soluble, CSF IL2R CSF 3003261
Interleukin 2 Receptor, Soluble, Plasma IL2R PLA 3002631
Interleukin 2 Receptor, Soluble, Serum IL2R DO 51529
Interleukin 4, Plasma IL4 PLA 3002622
Interleukin 4, Serum IL4 DO 51532
Interleukin 5, Plasma IL5 PLA 3002621
Interleukin 5, Serum IL5 DO 51533
Interleukin 6, CSF IL6 CSF 3003260
Interleukin 6, Plasma IL6 PLA 3002620
Interleukin 6, Serum IL6 DO 51537
Interleukin 8, Plasma IL8 PLA 3002619
Interleukin 8, Serum IL8 DO 51538
IRF4 by Immunohistochemistry IRF4 IHC 2003975
Kappa Light Chains by Immunohistochemistry KAPPA IHC 2000746
Keratin 903 (K903) High Molecular Weight by Immunohistochemistry K903 IHC 2003978
Lambda Light Chains by Immunohistochemistry LAMBDA IHC 2000751
Laminin by Immunohistochemistry LAMIN IHC 2001677
Langerin by Immunohistochemistry LANGER IHC 2013802
Luteinizing Hormone and Follicle Stimulating Hormone LH/FSH 70193
Luteinizing Hormone (LH) by Immunohistochemistry LH IHC 2010164
Luteinizing Hormone, Serum LH 70093
Lysozyme (Muramidase) by Immunohistochemistry LYSOZY IHC 2003990
Mannose Binding Lectin MBL 51692
Mast Cell Tryptase by Immunohistochemistry MASTCT IHC 2000757
Melan A by Immunohistochemistry MELANA IHC 2000758
Melan A RED by Immunohistochemistry MELA R IHC 3003729
Mib-1 (Ki-67) by Immunohistochemistry Mib1 IHC 2004519
MITF by Immunohistochemistry MITF IHC 2011998
Muc-1 by Immunohistochemistry MUC-1 IHC 2004002
Muc-4 by Immunohistochemistry MUC-4 IHC 2004008
Muscle-Specific Actin (MSA) by Immunohistochemistry MUSA IHC 2004011
Myeloperoxidase (MPO) by Immunohistochemistry MYELOP IHC 2004014
Myogenin (MYF4) by Immunohistochemistry MYF4 IHC 2004017
Myoglobin by Immunohistochemistry MYOGL IHC 2004031
Myoglobin, Serum MYOG-S 20224
Myoglobin, Urine MYOG-U 20223
Myosin by Immunohistochemistry MYOSIN IHC 2004034
Napsin A by Immunohistochemistry NAPSIN IHC 2008716
NeuN by Immunohistochemistry NEUN IHC 2004046
Neurofilament by Immunohistochemistry NEUROF IHC 2004049
Neuron Specific Enolase, Polyclonal (NSE P) by Immunohistochemistry NSE IHC 2004052
NKX2.2 by Immunohistochemistry NKX2.2 IHC 3004320
NUT by Immunohistochemistry IHC NUT 3002783
Octamer Transcription Factor-2 (OCT-2) IHC by Immunohistochemistry OCT-2 IHC 2004061
Octamer Transcription Factor-3 and -4 (Oct 3/4) by Immunohistochemistry OCT3/4 IHC 2004058
Osteocalcin by Electrochemiluminescent Immunoassay OSTEO NMID 20728
p16 by Immunohistochemistry P16 IHC 2004064
p40 by Immunohistochemistry P40 IHC 2010142
p53 by Immunohistochemistry P53 IHC 2004522
P501s by Immunohistochemistry P501S IHC 3001894
P504S by Immunohistochemistry P504S IHC 2000774
p57/Kip2 by Immunohistochemistry p57 IHC 2005542
p63 by Immunohistochemistry P63 IHC 2004073
Parathyroid Hormone, Fine Needle Aspiration (FNA) PTH FNA 2001491
Parathyroid Hormone, Intact PTH-INT 70346
Parathyroid Hormone, Intact with Calcium PTHI 70172
PAX5 by Immunohistochemistry PAX5 IHC 2004082
PAX8 by Immunohistochemistry PAX8 IHC 2010787
PD-1 by Immunohistochemistry PD1 IHC 2004085
PD-L1 by Immunohistochemistry PD-L1 IHC 2011158
PHF-Tau by Immunohistochemistry PHFTAU IHC 2004094
PIN4 (Prostate Triple Stain) by Immunohistochemistry PIN4 IHC 2010045
Placental Alkaline Phosphatase (PLAP) by Immunohistochemistry PLAP IHC 2000782
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 by Immunohistochemistry PSA IHC 2004112
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
PTH by Immunohistochemistry PTH IHC 2004118
RCC by Immunohistochemistry RCC IHC 2004124
Reflexed to Free PSA (Includes Free Percentage) BILL PSAFR 50338
Risk of Ovarian Malignancy Algorithm ROMA 2012618
ROS1 with Interpretation by Immunohistochemistry ROS 1 IP 2008414
S100 Protein by Immunohistochemistry S100 IHC 2004127
S100B CSF S100B CSF 2013358
S-100B Protein, Serum S 100B 2001766
S100 RED by Immunohistochemistry S100 R IHC 3003733
SALL4 by Immunohistochemistry SALL4 IHC 2005432
Sex Hormone Binding Globulin SHBG 99375
SMAD4 by Immunohistochemistry SMAD4 IHC 2006401
Smooth Muscle Actin (SMA) by Immunohistochemistry SMA IHC 2004130
SOX10 by Immunohistochemistry SOX10 IHC 3001562
SOX10 RED by Immunohistochemistry SOX10R IHC 3003737
SOX11 by Immunohistochemistry SOX11 IHC 2012561
STAT 6 by Immunohistochemistry STAT6 IHC 2013251
Surgical Pathology Tissue SP REQUEST 8090010
SV40 by Immunohistochemistry SV40 IHC 2004137
Synaptophysin by Immunohistochemistry SYNAPT IHC 2004139
T3 Uptake T3 UP 70135
TCL1 by Immunohistochemistry TCL1 IHC 3003595
TCR-delta by Immunohistochemistry TCR D IHC 3001896
TDP43 by Immunohistochemistry TDP43 IHC 3003407
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
TFE3 by Immunohistochemistry TFE3 IHC 2010688
Thyroglobulin Antibody ATHYG 50105
Thyroglobulin by Immunohistochemistry THYRO IHC 2004145
Thyroid Antibodies THYRO 50645
Thyroid Peroxidase (TPO) Antibody AMICR 50075
Thyroid Stimulating Hormone TSH 70145
Thyroid Stimulating Hormone Receptor Antibody (TRAb) TR AB 2002734
Thyroxine T4 70140
Thyroxine, Free (Free T4) FT4 70138
TIA-1 by Immunohistochemistry TIA-1 IHC 2004148
Toll-Like Receptor Function TLR 51589
Toxoplasmosis by Immunohistochemistry TOXOPL IHC 2004157
Transforming Growth Factor beta, Plasma TGFB PLA 51690
Transforming Growth Factor beta, Serum TGFB SER 51694
Treponema Pallidum by Immunohistochemistry TPALL IHC 3001704
Triiodothyronine, Free (Free T3) FT3 70133
Triiodothyronine, Total (Total T3) T3 TOTAL 70474
Troponin T (cTnT) 5th Generation CTNT 3001831
Trypsin by Immunohistochemistry TRYPS IHC 3003458
TTF-1 by Immunohistochemistry IHC TTF-1 2004166
Tumor Necrosis Factor - alpha, Plasma TNFA PLA 3002618
Tumor Necrosis Factor - alpha, Serum TNFA DO 51539
Ubiquitin by Immunohistochemistry UBIQUI IHC 2004169
Uroplakin-II by Immunohistochemistry UROPII IHC 3001149
Vimentin by Immunohistochemistry VIMENT IHC 2004181
WT-1 by Immunohistochemistry WT-1 IHC 2000810