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Analytical and clinical evaluations of Snibe Maglumi® S100B assay

  • Samy Kahouadji ORCID logo , Laure Picard , Valentin Bailly Defrance , Bruno Pereira , Damien Bouvier , Jean-Baptiste Bouillon-Minois und Vincent Sapin ORCID logo EMAIL logo
Veröffentlicht/Copyright: 10. Februar 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 7

Abstract

Objectives

To assess the analytical performances of Snibe Maglumi® S100 assay and compare it with the Roche Elecsys® S100B assay in adults with mild traumatic brain injury (mTBI) focusing on reducing unnecessary cranial computed tomography (CT) scans per Scandinavian and French guidelines.

Methods

Analytical performance of the Maglumi® S100 kit was assessed using quality controls from both Snibe and Roche, as well as pooled serums. Clinical performances were assessed using serum from 89 adult mTBI patients presenting to the adult emergency department of Clermont-Ferrand University Hospital with a Glasgow Coma Scale score of 14–15. CT scans were performed according to the Elecsys® S100 measurement, with a decision threshold of 0.10 μg/L.

Results

Repeatability and reproducibility coefficients of variation determined using Elecsys® S100B, Maglumi® S100 controls and pooled serums were below 8 %. Six (7 %) mTBI patients included had clinically relevant intracranial lesions observed on CT scan (CT+), and eighty-three (93 %) patients had no lesions (CT−). S100B medians in CT− and CT+ patients were significantly different: 0.125 (0.085–0.219) vs. 0.368 (0.231–0.489) (p=0.006) for Elecsys®, and 0.073 (0.046–0.140) vs. 0.327 (0.230–0.353) for Maglumi® (p=0.004). The areas under the ROC curves for intracranial lesion detection were similar: 0.82 (0.73–0.91; p=0.0084) and 0.83 (0.75–0.92; p=0.0063) for Elecsys® and Maglumi®, respectively.

Conclusions

The Maglumi® S100B assay can be used in the management of mTBI patients to exclude unnecessary CT scans. Further studies are needed to validate a clinical decision threshold for CT scan decisions.

Keywords: S100B; mild traumatic brain injury; mTBI; biomarker; Snibe; Roche
Corresponding author: Pr. Vincent Sapin, Service de Biochimie et Génétique Moléculaire, Centre de Biologie, CHU Gabriel Montpied, 58 Rue Montalembert, 63000 Clermont-Ferrand, France; and Université Clermont Auvergne, CNRS, INSERM, GReD, F-63000 Clermont-Ferrand, France, E-mail:

  1. Research ethics: This research complied with the tenets of the Helsinki Declaration (as revised in 2013), and has received approval by the French Patient Protection Committee (CPP Ile-de-France X) (Reference 52–2019).

  2. Informed consent: Patients were informed of their right to express their disagreement regarding the use of their clinical information for research purposes.

  3. Author contributions: Samy KAHOUADJI: Investigation, Writing – Original Draft. Laure PICARD: investigation. Valentin BAILLY DEFRANCE: investigation. Bruno PEREIRA: Methodology, Formal analysis. Damien BOUVIER: Writing – Review & Editing. Jean-Baptiste BOUILLON-MINOIS: Supervision, Validation. Vincent SAPIN: Conceptualization, Writing – Review & Editing, Supervision, Validation. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: DeepL was used for some translations and redaction assistance.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Data is confidential and cannot be shared publicly. Data can be available for researchers who meet the criteria for access to confidential data.

References

1. Tagliaferri, F, Compagnone, C, Korsic, M, Servadei, F, Kraus, J. A systematic review of brain injury epidemiology in Europe. Acta Neurochir 2006;148:255–68. discussion 268. https://doi.org/10.1007/s00701-005-0651-y.Suche in Google Scholar PubMed

2. Cassidy, JD, Carroll, LJ, Peloso, PM, Borg, J, von Holst, H, Holm, L, et al.. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO collaborating centre task force on mild traumatic brain injury. J Rehabil Med 2004:28–60. https://doi.org/10.1080/16501960410023732.Suche in Google Scholar PubMed

3. Vos, PE, Alekseenko, Y, Battistin, L, Ehler, E, Gerstenbrand, F, Muresanu, DF, et al.. Mild traumatic brain injury. Eur J Neurol 2012;19:191–8. https://doi.org/10.1111/j.1468-1331.2011.03581.x.Suche in Google Scholar PubMed

4. Mutch, CA, Talbott, JF, Gean, A. Imaging evaluation of acute traumatic brain injury. Neurosurg Clin 2016;27:409–39. https://doi.org/10.1016/j.nec.2016.05.011.Suche in Google Scholar PubMed PubMed Central

5. Pearce, MS, Salotti, JA, Little, MP, McHugh, K, Lee, C, Kim, KP, et al.. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet 2012;380:499–505. https://doi.org/10.1016/s0140-6736(12)60815-0.Suche in Google Scholar PubMed PubMed Central

6. Czeiter, E, Amrein, K, Gravesteijn, BY, Lecky, F, Menon, DK, Mondello, S, et al.. Blood biomarkers on admission in acute traumatic brain injury: relations to severity, CT findings and care path in the CENTER-TBI study. EBioMedicine 2020;56:102785. https://doi.org/10.1016/j.ebiom.2020.102785.Suche in Google Scholar PubMed PubMed Central

7. Kahouadji, S, Salamin, P, Praz, L, Coiffier, J, Frochaux, V, Durif, J, et al.. S100B blood level determination for early management of ski-related mild traumatic brain injury: a pilot study. Front Neurol 2020;11:856. https://doi.org/10.3389/fneur.2020.00856.Suche in Google Scholar PubMed PubMed Central

8. 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;25:228–40. https://doi.org/10.1097/htr.0b013e3181e57e22.Suche in Google Scholar PubMed

9. Oris, C, Kahouadji, S, Durif, J, Bouvier, D, Sapin, V. S100B, actor and biomarker of mild traumatic brain injury. Int J Mol Sci 2023;24:6602. https://doi.org/10.3390/ijms24076602.Suche in Google Scholar PubMed PubMed Central

10. Biberthaler, P, Linsenmeier, U, Pfeifer, KJ, Kroetz, M, Mussack, T, Kanz, KG, et al.. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock 2006;25:446–53. https://doi.org/10.1097/01.shk.0000209534.61058.35.Suche in Google Scholar PubMed

11. Bouvier, D, Oddoze, C, Ben Haim, D, Moustafa, F, Legrand, A, Alazia, M, et al.. Intérêt du dosage sérique de la protéine S100B dans la prise en charge du patient après traumatisme crânien léger. Ann Biol Clin 2009;67:425–31. https://doi.org/10.1684/abc.2009.0347.Suche in Google Scholar PubMed

12. Allouchery, G, Moustafa, F, Roubin, J, Pereira, B, Schmidt, J, Raconnat, J, et al.. Clinical validation of S100B in the management of a mild traumatic brain injury: issues from an interventional cohort of 1449 adult patients. Clin Chem Lab Med 2018;56:1897–904. https://doi.org/10.1515/cclm-2018-0471.Suche in Google Scholar PubMed

13. Oris, C, Kahouadji, S, Bouvier, D, Sapin, V. Blood biomarkers for the management of mild traumatic brain injury in clinical practice. Clin Chem 2024;70:1023–36. https://doi.org/10.1093/clinchem/hvae049.Suche in Google Scholar PubMed

14. Oris, C, Bouillon-Minois, JB, Kahouadji, S, Pereira, B, Dhaiby, G, Defrance, VB, et al.. S100B vs. “GFAP and UCH-L1” assays in the management of mTBI patients. Clin Chem Lab Med 2024;62:891–9. https://doi.org/10.1515/cclm-2023-1238.Suche in Google Scholar PubMed

15. Lagares, A, de la Cruz, J, Terrisse, H, Mejan, O, Pavlov, V, Vermorel, C, et al.. An automated blood test for glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) to predict the absence of intracranial lesions on head CT in adult patients with mild traumatic brain injury: BRAINI, a multicentre observational study in Europe. EBioMedicine 2024;110:105477. https://doi.org/10.1016/j.ebiom.2024.105477.Suche in Google Scholar PubMed PubMed Central

16. Delefortrie, Q, Lejeune, F, Kerzmann, B, Levy, R, Adam, JF, Sottiaux, T, et al.. Evaluation of the Roche® Elecsys and the Diasorin® Liaison S100 kits in the management of mild head injury in the emergency room. Clin Biochem 2018;52:123–30. https://doi.org/10.1016/j.clinbiochem.2017.11.004.Suche in Google Scholar PubMed

17. Bouvier, D, Duret, T, Rouzaire, P, Jabaudon, M, Rouzaire, M, Nourrisson, C, et al.. Preanalytical, analytical, gestational and pediatric aspects of the S100B immuno-assays. Clin Chem Lab Med 2016;54:833–42. https://doi.org/10.1515/cclm-2015-0771.Suche in Google Scholar PubMed

18. Gil-Jardiné, C, Payen, JF, Bernard, R, Bobbia, X, Bouzat, P, Catoire, P, et al.. Management of patients suffering from mild traumatic brain injury 2023. Anaesthesia Critical Care Pain Med 2023;42:101260. https://doi.org/10.1016/j.accpm.2023.101260.Suche in Google Scholar PubMed

19. Laribi, S, Kansao, J, Borderie, D, Collet, C, Deschamps, P, Ababsa, R, et al.. S100B blood level measurement to exclude cerebral lesions after minor head injury: the multicenter STIC-S100 French study. Clin Chem Lab Med 2014;52:527–36. https://doi.org/10.1515/cclm-2013-0621.Suche in Google Scholar PubMed

20. Oris, C, Chabanne, R, Durif, J, Kahouadji, S, Brailova, M, Sapin, V, et al.. Measurement of S100B protein: evaluation of a new prototype on a bioMérieux Vidas® 3 analyzer. Clin Chem Lab Med 2019;57:1177–84. https://doi.org/10.1515/cclm-2018-1217.Suche in Google Scholar PubMed

Received: 2024-12-28
Accepted: 2025-01-28
Published Online: 2025-02-10
Published in Print: 2025-06-26

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1508
Schlagwörter für diesen Artikel
S100B; mild traumatic brain injury; mTBI; biomarker; Snibe; Roche

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. The journey to pre-analytical quality
  4. Manual tilt tube method for prothrombin time: a commentary on contemporary relevance
  5. Reviews
  6. From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review
  7. Advancements and challenges in high-sensitivity cardiac troponin assays: diagnostic, pathophysiological, and clinical perspectives
  8. Opinion Paper
  9. Is it feasible for European laboratories to use SI units in reporting results?
  10. Perspectives
  11. What does cancer screening have to do with tomato growing?
  12. Computer simulation approaches to evaluate the interaction between analytical performance characteristics and clinical (mis)classification: a complementary tool for setting indirect outcome-based analytical performance specifications
  13. Genetics and Molecular Diagnostics
  14. Artificial base mismatches-mediated PCR (ABM-PCR) for detecting clinically relevant single-base mutations
  15. Candidate Reference Measurement Procedures and Materials
  16. Antiphospholipid IgG Certified Reference Material ERM®-DA477/IFCC: a tool for aPL harmonization?
  17. General Clinical Chemistry and Laboratory Medicine
  18. External quality assessment of the manual tilt tube technique for prothrombin time testing: a report from the IFCC-SSC/ISTH Working Group on the Standardization of PT/INR
  19. Simple steps to achieve harmonisation and standardisation of dried blood spot phenylalanine measurements and facilitate consistent management of patients with phenylketonuria
  20. Inclusion of pyridoxine dependent epilepsy in expanded newborn screening programs by tandem mass spectrometry: set up of first and second tier tests
  21. Analytical performance evaluation and optimization of serum 25(OH)D LC-MS/MS measurement
  22. Towards routine high-throughput analysis of fecal bile acids: validation of an enzymatic cycling method for the quantification of total bile acids in human stool samples on fully automated clinical chemistry analyzers
  23. Analytical and clinical evaluations of Snibe Maglumi® S100B assay
  24. Prevalence and detection of citrate contamination in clinical laboratory
  25. Reference Values and Biological Variations
  26. Temporal dynamics in laboratory medicine: cosinor analysis and real-world data (RWD) approaches to population chronobiology
  27. Establishing sex- and age-related reference intervals of serum glial fibrillary acid protein measured by the fully automated lumipulse system
  28. Hematology and Coagulation
  29. Performance of the automated digital cell image analyzer UIMD PBIA in white blood cell classification: a comparative study with sysmex DI-60
  30. Cancer Diagnostics
  31. Flow-cytometric MRD detection in pediatric T-ALL: a multicenter AIEOP-BFM consensus-based guided standardized approach
  32. Impact of biological and genetic features of leukemic cells on the occurrence of “shark fins” in the WPC channel scattergrams of the Sysmex XN hematology analyzers in patients with chronic lymphocytic leukemia
  33. Assessing the clinical applicability of dimensionality reduction algorithms in flow cytometry for hematologic malignancies
  34. Cardiovascular Diseases
  35. Evaluation of sex-specific 0-h high-sensitivity cardiac troponin T thresholds for the risk stratification of non-ST-segment elevation myocardial infarction
  36. Retraction
  37. The first case of Teclistamab interference with serum electrophoresis and immunofixation
  38. Letters to the Editor
  39. Is this quantitative test fit-for-purpose?
  40. Reply to “Is this quantitative test fit-for-purpose?”
  41. Short-term biological variation of coagulation and fibrinolytic measurands
  42. The first case of Teclistamab interference with serum electrophoresis and immunofixation
  43. Imlifidase: a new interferent on serum protein electrophoresis looking as a rare plasma cell dyscrasia
  44. Research on the development of image-based Deep Learning (DL) model for serum quality recognition
  45. Interference of hypertriglyceridemia on total cholesterol assay with the new CHOL2 Abbott method on Architect analyser
  46. Congress Abstracts
  47. 10th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
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