S-100B Protein, Serum

CPT: 86316
Updated on 01/21/2025
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Special Instructions

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.


Expected Turnaround Time

7 - 10 days


Related Documents


Specimen Requirements


Specimen

Serum


Volume

0.5 mL


Minimum Volume

0.3 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or serum-separator tube


Collection

If tube other than a gel-barrier tube is used, transfer separated serum to a plastic transport tube.


Storage Instructions

Refrigerate.


Stability Requirements

TemperaturePeriod
Room temperature3 days
Refrigerated14 days
Frozen14 days
Freeze/thaw cyclesStable x1

Causes for Rejection

Non serum sample received; improper labeling

Improper labeling

Non serum sample received; improper labeling


Test Details


Use

This test is used for the measurement of the level of S-100B Protein in serum.


Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. 

Testing is performed by the Fujirebio Diagnostics CanAg Enzyme Linked Immunoassay (ELISA) method. Values obtained with different assay methods or kits cannot be used interchangeably. 

S-100B can be found in abnormal levels in many pathological conditions, including liver, brain and renal injury, inflammatory and infectious processes.1 The use of S-100B is limited by its lack of specificity as extra-cerebral sources produce increases in levels of S-100B in the setting of hemorrhagic shock, circulatory arrest or during cardiopulmonary bypass.2

Anti-reagent antibodies (human anti-mouse antibody (HAMA) or heterophilic antibodies) in the sample may occasionally interfere with the assay even though specific blocking agents are included in the buffer. 

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

S-100B values determined on patient samples by different test procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.

S-100B can be found in abnormal levels in many pathological conditions, including liver, brain and renal injury, inflammatory and infectious processes.1

The use of S-100B is limited by its lack of specificity as extra-cerebral sources produce increases in levels of S-100B in the setting of hemorrhagic shock, circulatory arrest or during cardiopulmonary bypass.2

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. 

Testing is performed by the Fujirebio Diagnostics CanAg Enzyme Linked Immunoassay (ELISA) method. Values obtained with different assay methods or kits cannot be used interchangeably. 

S-100B can be found in abnormal levels in many pathological conditions, including liver, brain and renal injury, inflammatory and infectious processes.1 The use of S-100B is limited by its lack of specificity as extra-cerebral sources produce increases in levels of S-100B in the setting of hemorrhagic shock, circulatory arrest or during cardiopulmonary bypass.2

Anti-reagent antibodies (human anti-mouse antibody (HAMA) or heterophilic antibodies) in the sample may occasionally interfere with the assay even though specific blocking agents are included in the buffer. 

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation.


Methodology

CanAg® S100 Enzyme Immunoassay


Reference Interval

See table.

Age (y)(ng/L)
0 to 2 y63.4–386.8
3 to 19 y43.3–204.5
20 to 60 y20.6–103.7
>60 y15.5–129.0

Additional Information

S100 proteins are localized in the cytoplasm and nucleus of a wide range of cells and play a role in the regulation of a number of cellular processes including cell cycle progression and differentiation.3 S100 calcium binding protein B, or S-100B, is localized predominantly in astrocytes and Swans cells of the central nervous system. Small amounts of S-100B are also found in peripheral locations including adipocytes, melanocytes and other cells.3

Serum S-100B levels can be increased in various neoplastic and neuropathologic conditions including melanomas, malignant peripheral nerve sheath tumors, schwannomas, paraganglioma stromal cells, histiocytoma and clear cell sarcomas.4 In clinical practice, S-100B is mainly used as protein tumor marker for assessment of melanoma patients.5-11 S-100B serum levels can reflect tumor load, correlate with response to treatment, identify patients who are at increased risk of disease relapse, may predict prognosis and could be used as early biomarkers of tumor recurrence.12 For patients with high-risk surgically resected melanoma, a high baseline or increasing serum S-100B is an independent prognostic marker of risk for mortality13 and normal values predict prolonged survival for stage IV melanoma patients.14 The measurement of S-100B in the diagnosis, follow-up and therapeutic monitoring of malignant melanoma has been suggested by Swiss,6 German7,15 and European Society for Medical Oncology (ESMO)16 guidelines.

S-100B has been employed as a screening, monitoring and prediction tool in the management of traumatic brain injury (TBI) patients,17-25 and it has been included into several guidelines as pre-head CT screening test.19,26-28 S-100B levels are significantly higher in children with TBI compared with healthy matched controls29 and higher in children with a lower presenting Glasgow Coma Scale scores.30 A high S-100B level at admission was associated with poor outcomes at hospital discharge.31 Outcome at 6 months post-injury, assessed using the Glasgow Outcome Score, is associated with S-100B levels at admission32,33 and at one week following injury.30 Time to peak S-100B levels was associated with neurocognitive outcome.34 Two other studies found that admission levels were associated with poor outcome at 12 months post-injury.29,35


Footnotes

1. Molina R, Navarro J, Filella X, Castel T, Ballesta AM. S-100 protein serum levels in patients withbenign and malignant diseases: false-positive results related to liver and renal function. Tumour Biol. 2002 Jan-Feb;23(1):39-44.11893905
2. Kochanek PM, Berger RP, Bayir H, Wagner AK, Jenkins LW, Clark RSB. Biomarkers of primary and evolving damage in traumatic and ischemic brain injury: diagnosis, prognosis, probing mechanisms, and therapeutic decision making. Curr Opin Crit Care. 2008 Apr;14(2):135-141.18388674
3. Donato R, Cannon BR, Sorci G, et al. Functions of S100 proteins. Curr Mol Med. 2013 Jan;13(1):24-57.22834835
4. Salama I, Malone PS, Mihaimeed F, Jones JL. A review of the S100 proteins in cancer. Eur J Surg Oncol. 2008 Apr;34(4):357-364.17566693
5. Gogas H, Eggermont AM, Hauschild A, et al. Biomarkers in melanoma. Ann Oncol. 2009 Aug;20 Suppl 6(Suppl 6):vi8-13.19617299
6. Garbe C, Amaral T, Peris K, et al. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics - Update 2019. Eur J Cancer. 2020 Feb;126:141-158.31928887
7. Kruijff S, Hoekstra HJ. The current status of S-100B as a biomarker in melanoma. Eur J Surg Oncol. 2012 Apr;38(4):281-285.22240030
8. Dummer R, Siano M, Hunger RE, et al. The updated Swiss guidelines 2016 for the treatment and follow-up of cutaneous melanoma. Swiss Med Wkly. 2016 Feb 22;146:w14279.26901103
9. Garbe C, Schadendorf D, Stolz W, et al. Short German guidelines: malignant melanoma. J Dtsch Dermatol Ges. 2008 May;6 Suppl 1:S9-S144.18801142
10. Mocellin S, Zavagno G, Nitti D. The prognostic value of serum S100B in patients with cutaneous melanoma: a meta-analysis. Int J Cancer. 2008 Nov 15;123(10):2370-2376.18752249
11. Gassenmaier M, Lenders MM, Forschner A, et al. Serum S100B and LDH at Baseline and During Therapy Predict the Outcome of Metastatic Melanoma Patients Treated with BRAF Inhibitors. Target Oncol. 2021 Mar;16(2):197-205.33555543
12. Karonidis A, Mantzourani M, Gogas H, Tsoutsos D. Serum S100B levels correlate with stage, N status, mitotic rate and disease outcome in melanoma patients independent to LDH. J BUON. 2017 Sep-Oct;22(5):1296-1302.29135116
13. Tarhini AA, Stuckert J, Lee S, Sander C, Kirkwood JM. Prognostic significance of serum S100B protein in high-risk surgically resected melanoma patients participating in Intergroup Trial ECOG 1694. J Clin Oncol. 2009 Jan 1;27(1):38-44.19047287
14. Smit LH, Korse CM, Hart AA, et al. Normal values of serum S-100B predict prolonged survival for stage IV melanoma patients. Eur J Cancer. 2005 Feb;41(3):386-392.15691637
15. Pflugfelder A, Kochs C, Blum A, et al. Malignant melanoma S3-guideline "diagnosis, therapy and follow-up of melanoma". J Dtsch Dermatol Ges. 2013 Aug;11 Suppl 6:1-116, 1-126.24028775
16. Dummer R, Hauschild A, Guggenheim M, Jost L, Pentheroudakis G, ESMO Guidelines Working Group. Melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v194-197.20555080
17. Thelin EP, Nelson DW, Bellander BM. A review of the clinical utility of serum S100B protein levels in the assessment of traumatic brain injury. Acta Neurochir (Wien). 2017 Feb;159(2):209-225.27957604
18. Schulte S, Podlog LW, Hamson-Utley JJ, Strathmann FG, Strüder HK. A systematic review of the biomarker S100B: implications for sport-related concussion management. J Athl Train. 2014 Nov-Dec;49(6):830-850.25299445
19. Undén J, Ingebrigtsen T, Romner B, Scandinavian Neurotrauma Committee (SNC). Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults: an evidence and consensus-based update. BMC Med. 2013 Feb 25;11:50.23432764
20. Ercole A, Thelin EP, Holst A, Bellander BM, Nelson DW. Kinetic modelling of serum S100b after traumatic brain injury. BMC Neurol. 2016 Jun 17;16:93.27315805
21. Undén J, Romner B. Can low serum levels of S100B predict normal CT findings after minor head injury in adults?: an evidence-based review and meta-analysis. J Head Trauma Rehabil. 2010 Jul-Aug;25(4):228-240.20611042
22. Thaler HW, Schmidsfeld J, Pusch M, et al. Evaluation of S100B in the diagnosis of suspected intracranial hemorrhage after minor head injury in patients who are receiving platelet aggregation inhibitors and in patients 65 years of age and older. J Neurosurg. 2015 Nov;123(5):1202-1208.26148794
23. Olivecrona Z, Bobinski L, Koskinen LOD. Association of ICP, CPP, CT findings and S-100B and NSE in severe traumatic head injury. Prognostic value of the biomarkers. Brain Inj. 2015;29(4):446-454.25518864
24. Sandler SJI, Figaji AA, Adelson PD. Clinical applications of biomarkers in pediatric traumatic brain injury. Childs Nerv Syst. 2010 Feb;26(2):205-213.19902222
25. Haselmann V, Schamberger C, Trifonova F, et al. Plasma-based S100B testing for management of traumatic brain injury in emergency setting. Pract Lab Med. 2021 May 12;26:e00236.34041343
26. Vedin T, Karlsson M, Edelhamre M, et al. A proposed amendment to the current guidelines for mild traumatic brain injury: reducing computerized tomographies while maintaining safety. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1451-1459.31089789
27. Jagoda AS, Bazarian JJ, Bruns Jr JJ, et al. Clinical policy: neuroimaging and decisionmaking in adult mild traumatic brain injury in the acute setting. J Emerg Nurs. 2009 Apr;35(2):e5-40.19285163
28. Calcagnile O, Anell A, Undén J. The addition of S100B to guidelines for management of mild head injury is potentially cost saving. BMC Neurol. 2016 Oct 20;16(1):200.27765016
29. Berger RP, Pierce MC, Wisniewski SR, Adelson PD, Kochanek PM. Serum S100B concentrations are increased after closed head injury in children: a preliminary study. J Neurotrauma. 2002 Nov;19(11):1405-1409.12490005
30. Park DW, Park SH, Hwang SK. Serial measurement of S100B and NSE in pediatric traumatic brain injury. Childs Nerv Syst. 2019 Feb;35(2):343-348.30171330
31. Spinella PC, Dominguez T, Drott HR, et al. S-100beta protein-serum levels in healthy children and its association with outcome in pediatric traumatic brain injury. Crit Care Med. 2003 Mar;31(3):939-945.12627009
32. Žurek J, Fedora M. The usefulness of S100B, NSE, GFAP, NF-H, secretagogin and Hsp70 as a predictive biomarker of outcome in children with traumatic brain injury. Acta Neurochir (Wien). 2012 Jan;154(1):93-103; discussion 103.21976236
33. Townend W, Dibble C, Abid K, Vail A, Sherwood R, Lecky F. Rapid elimination of protein S-100B from serum after minor head trauma. J Neurotrauma. 2006 Feb;23(2):149-155.16503799
34. Beers SR, Berger RP, Adelson PD. Neurocognitive outcome and serum biomarkers in inflicted versus non-inflicted traumatic brain injury in young children. J Neurotrauma. 2007 Jan;24(1):97-105.17263673
35. Wilkinson AA, Simic N, Frndova H, et al. Serum Biomarkers Help Predict Attention Problems in Critically Ill Children With Traumatic Brain Injury. Pediatr Crit Care Med. 2016 Jul;17(7):638-648.27167007

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