Skip to main content

Standardization of Cardiac Markers

  • Chapter
Book cover Cardiac Markers

Part of the book series: Pathology and Laboratory Medicine ((PLM))

Abstract

The development of commercially available assays for the determination of cardiac proteins has been one of the most important innovations in the field of cardiovascular diagnostics in the last decade. The availability of innovative procedures to detect myoglobin, creatine kinase isoenzyme MB (CK-MB) mass concentration, and, above all, cardiac troponins now represents a major opportunity to improve significantly clinical assessment of the acute coronary syndrome (ACS) (1). The routine clinical use of the measurement of the catalytic activity of “cardiac” enzymes, that is, lactate dehydrogenase, aspartate aminotransferase, CK and CK-MB, has gradually been replaced—although at different speeds in various countries—by automated quantitative immunoassays for mass determination of myoglobin, CK-MB, cardiac troponin I (cTnI), and cardiac troponin T (cTnT) (2).

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Panteghini M, Apple FS, Christenson RH, Dati F, Mair J, Wu AH. Use of biochemical markers in acute coronary syndromes. IFCC Scientific Division, Committee on Standardization of Markers of Cardiac Damage. Clin Chem Lab Med 1999; 37: 687–693.

    PubMed  CAS  Google Scholar 

  2. Apple FS, Murakami M, Panteghini M, et al., on behalf of the IFCC Committee on Standardization of Markers of Cardiac Damage. International survey on the use of cardiac markers. Clin Chem 2001; 47: 587–588.

    PubMed  CAS  Google Scholar 

  3. Panteghini M, Pagani F, Bonetti G. The sensitivity of cardiac markers: an evidence-based approach. Clin Chem Lab Med 1999; 37: 1097–1106.

    PubMed  CAS  Google Scholar 

  4. Panteghini M. Diagnostic application of CK-MB mass determination. Clin Chim Acta 1998; 72: 23–31.

    Article  Google Scholar 

  5. Alpert J, Thygesen K, Antman E, Bassand JP, for the Joint European Society of Cardiology/ American College of Cardiology Committee. Myocardial infarction redefined-A consensus document of the Joint European Society of Cardiology/American College of Cardiology Cornmittee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol 2000; 36: 959–969.

    Article  PubMed  CAS  Google Scholar 

  6. Stöckl D, Franzini C, Kratochvila J, Middle J, Ricos C, Thienpont LM. Current stage of standardization of measurements of specific polypeptides and proteins discussed in light of steps needed towards a comprehensive measurement system. Eur J Clin Chem Clin Biochem 1997; 35: 719–732.

    PubMed  Google Scholar 

  7. Müller MM. Implementation of reference systems in laboratory medicine. Clin Chem 2000; 46: 1907–1909.

    PubMed  Google Scholar 

  8. Labugger R, Organ L, Collier C, Atar D, Van Eyk JE. Extensive troponin I and T modification detected in serum from patients with acute myocardial infarction. Circulation 2000; 102: 1221–1226.

    Article  PubMed  CAS  Google Scholar 

  9. Panteghini M, Gerhardt W, Apple FS, Dati F, Ravkilde J, Wu AH. Quality specifications for cardiac troponin assays. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). IFCC Scientific Division Committee on Standardization of Markers of Cardiac Damage. Clin Chem Lab Med 2001; 39: 174–178.

    Google Scholar 

  10. International Organization for Standardization-ISO. Terms and definitions used in connection with reference materials. ISO Guide 30: 1992.

    Google Scholar 

  11. Dybkaer R. Reference materials-a main element in a coherent measurement system. Eur J Clin Chem Clin Biochem 1991; 29: 241–246.

    PubMed  CAS  Google Scholar 

  12. Dati F, Panteghini M, Apple FS, Christenson RH, Mair J, Wu AH. Proposals from the IFCC Committee on Standardization of Markers of Cardiac Damage (C-SMCD): strategies and concepts on standardization of cardiac marker assays. Scand J Clin Lab Invest 1999; 59 (Suppl 230): 113–123.

    Google Scholar 

  13. Gella FJ, Frey E, Ceriotti F, et al. Production and certification of an enzyme reference material for creatine kinase isoenzyme 2 (CRM 608). Clin Chim Acta 1998; 276: 35–52.

    Article  PubMed  CAS  Google Scholar 

  14. Schreiber A, Specht B, Pelsers MMAL, Glatz JFZ, Börchers T, Spener F. Recombinant human heart-type fatty acid-binding protein as standard in immunochemical assays. Clin Chem Lab Med 1998; 36: 283–288.

    Article  PubMed  CAS  Google Scholar 

  15. Liu SG, Shi QW, Song QL, et al. Development and analysis of recombinant human cardiac troponin complexes for immunoassay controls and calibrators. Clin Chem 1998; 44 (Suppl): A21.

    Google Scholar 

  16. Zhang MY, Song QL, Shi QW, Kadijevic L, Liu SG. Recombinant single chain cardiac troponin I-C polypeptide: an ideal stable control material for cardiac troponin I immunoassays. Clin Chem 1999; 45 (Suppl): A53.

    Google Scholar 

  17. Christenson RH, Vaidya H, Landt Y, et al. Standardization of creatine kinase-MB (CK-MB) mass assays: the use of recombinant CK-MB as a reference material. Clin Chem 1999; 45: 1414–1423.

    PubMed  CAS  Google Scholar 

  18. Liu S, Zhang M, Ling Q, et al. The second generation of recombinant single chain cardiac troponin I-C polypeptide: a superior stable control material for cardiac troponin I immunoassays. Clin Chem 2000; 46 (Suppl): A179 - A180.

    Google Scholar 

  19. Sunahara Y, Uchida K, Tanaka T, Matsukawa H, Inagaki M, Matuo Y. Production of recombinant human creatine kinase (r-hCK) isozymes by tandem repeat expression of M and B genes and characterization of r-hCK-MB. Clin Chem 2001; 47: 471–476.

    PubMed  CAS  Google Scholar 

  20. Tobias R, Pekatch T, Frater Y, Styba G, McClure S, Jackowski S. Herne reconstitution and folding of recombinant myoglobin. Clin Chem 1997; 43: S158.

    Google Scholar 

  21. Whicher JT. Calibration is the key to immunoassay but the ideal calibrator is unattainable. Scand J Clin Lab Invest 1991; 51 (Suppl 205): 21–32.

    Article  Google Scholar 

  22. Ekins R. Immunoassay standardization. Scand J Clin Lab Invest 1991; 51 (Suppl 205): 33–46.

    Article  Google Scholar 

  23. Christenson RH, Duh SH, Apple FS, et al. Standardization of cardiac troponin I assays: round robin of ten candidate reference materials. Clin Chem 2001; 47: 431–437.

    PubMed  CAS  Google Scholar 

  24. Sanchez M, Canalias F, Palencia T, Gella FJ. Creatine kinase 2 mass measurement: methods comparison and study of the matrix effect. Clin Chim Acta 1999; 288: 111–119.

    Article  PubMed  CAS  Google Scholar 

  25. Sanchez M, Gella FJ, Profilis C, et al. Certification of the mass concentration of creatine kinase isoenzyme 2 (CK-MB) in the reference material BCR 608. Clin Chem Lab Med 2001; 39: 858–865.

    Article  PubMed  CAS  Google Scholar 

  26. Kahn SE, Apple FS, Bodor GS, et al. Standardization of cardiac troponin I assays: pilot evaluation of ten candidate reference materials. Clin Chem 2000; 46 (Suppl): A89.

    Google Scholar 

  27. Stenman UH. Immunoassay standardization: is it possible, who is responsible, who is capable? Clin Chem 2001; 47: 815–820.

    PubMed  CAS  Google Scholar 

  28. Bender D, Tobias R, Shaikh N. Patient-based CK-MB calibrators: a potential commutable/ secondary standard for CK-MB immunoassay instrumentation. Clin Chem 2001; 47 (Suppl): A202.

    Google Scholar 

  29. Tobias RB, Bender D, Pituley A, Shi Q, Shaikh N Development of clinical-based and recombinant calibrators for myoglobin diagnostic tests. Clin Chem 2001; 47 (Suppl): A203 - A204.

    Google Scholar 

  30. Whicher JT, Ritchie RF, Johnson AM, et al. New international reference preparation for proteins in human serum (RPPHS). Clin Chem 1994; 40: 934–938.

    PubMed  CAS  Google Scholar 

  31. Cattozzo G, Franzini C, Melzi d’Eril GV. Myoglobin and creatine kinase isoenzyme MB mass assays: intermethod behaviour of patient sera and commercially available control materials. Clin Chim Acta 2001; 303: 55–60.

    Article  PubMed  CAS  Google Scholar 

  32. Rej R, Drake P. The nature of calibrators in immunoassays: Are they commutable with test samples? Must they be? Scand J Clin Lab Invest 1991; 51 (Suppl 205): 47–54.

    Article  Google Scholar 

  33. Moss DW, Whicher JT. Commutability and the problem of method-dependent results. Eur J Clin Chem Clin Biochem 1995; 33: 1003–1007.

    PubMed  CAS  Google Scholar 

  34. Barr JR, Maggio VL, Patterson DG, et al. Isotope dilution-mass spectrometric quantification of specific proteins: model application with apoliprotein A-I. Clin Chem 1996; 42: 1676–1682.

    PubMed  CAS  Google Scholar 

  35. Panteghini M, Ceriotti F, Schumann G, Siekmann L. Establishing a reference system in clinical enzymology. Clin Chem Lab Med 2001; 39: 795–800.

    PubMed  CAS  Google Scholar 

  36. Katrukha AG, Bereznikova AV, Filatov VL, et al. Degradation of cardiac troponin I: implication for reliable immunodetection. Clin Chem 1998; 44: 2433–2440.

    PubMed  CAS  Google Scholar 

  37. Green S, Onoroski M, Moore R, Wu A, Lehrer M, Vaidya H and the AACC CK-MB mass assay standardization subcommittee (MB-MASS). Standardization of CK-MB mass immunoassays. Clin Chem 1994; 40: 1032.

    Google Scholar 

  38. Panteghini M. Update on cardiac troponin standardization. Biochim Clin 2001; 25: 275–276.

    Google Scholar 

  39. Panteghini M. IFCC Committee on Standardization of Markers of Cardiac Damage: premises and project presentation. Clin Chem Lab Med 1998; 36: 887–893.

    Article  PubMed  CAS  Google Scholar 

  40. Panteghini M. Standardization activities of markers of cardiac damage: the need of a comprehensive approach. Eur Heart J 1998; 19 (Suppl N): N8 - N11.

    PubMed  Google Scholar 

  41. International Organization for Standardization, European Committee for Standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-metrological traceability of values assigned to calibrators and control materials. ISO/TC 212/WG2 N65 prEN 17511. Geneva, Switzerland: International Organization for Standardization, 2000.

    Google Scholar 

  42. Panteghini M, Apple FS, Christenson RH, Dati F, Mair J, Wu AH. Recent approaches in standardization of cardiac markers. Clin Chem Lab Med 1999; 37 (Suppl): S112.

    Google Scholar 

  43. Wu AHB, Feng YJ, Moore R, Apple FS, McPherson PH, Buechler KF, Bodor G, for the American Association for Clinical Chemistry subcommittee on cTnI standardization. Characterization of cardiac troponin subunit release into serum after acute myocardial infarction and comparison of assays for troponin T and I. Clin Chem 1998; 44: 1198–1208.

    Google Scholar 

  44. Shi Q, Zhang MY, Kadijevic L, Liu S. Creation of a commutable cardiac troponin I calibration material. Clin Chem 2001; 47 (Suppl): A27.

    Google Scholar 

  45. Zaninotto M, Pagani F, Altinier S, et al. Multicenter evaluation of five assays for myoglobin determination. Clin Chem 2000; 46: 1631–1637.

    PubMed  CAS  Google Scholar 

  46. Yeo KTJ, Quinn-Hall KS, Bateman SW, Fischer GA, Wieczorek S, Wu AHB. Functional sensitivity of cardiac troponin assays and its implications for risk stratification of patients with acute coronary syndromes. In: Markers in Cardiology: Current and Future Clinical Applications. Adams JE III, Apple FS, Jaffe AS, Wu AHB, eds. Armonk, NY: Futura, 2001, pp. 23–29.

    Google Scholar 

  47. Pagani F, Bonetti G, Stefini F, Cuccia C, Panteghini M. Determination of decision limits for ACS: systems cardiac troponin I. Clin Chem Lab Med 2000; 38: 1155–1157.

    PubMed  CAS  Google Scholar 

  48. Stiegler H, Fisher Y, Vazquez-Jimenez JF, et al. Lower cardiac troponin T and I results in heparin-plasma than in serum. Clin Chem 2000; 46: 1338–1344.

    PubMed  CAS  Google Scholar 

  49. Wu AHB. Laboratory and near patient testing for cardiac markers. J Clin Ligand Assay 1999; 22: 32–37.

    Google Scholar 

  50. Wu A, Apple F, Venge P, et al. Analytical performance of Beckman Coulter’s Access AccuTnl (troponin I) in a multicenter evaluation. Clin Chem Lab Med 2001; 39 (Suppl): S191.

    Google Scholar 

  51. Bataillon S, Incaurgarat B, Varret F, et al. Preliminary evaluation of the Vidas cardiac troponin I assay. Clin Chem Lab Med 2001; 39 (Suppl): S195.

    Google Scholar 

  52. Kaminski D, Sivakoff S, McCormack B, Pierson-Perry J. Development and analytical performance of an improved method for cardiac troponin-I on the Dade Behring Dimension clinical chemistry system. Clin Chem 2001; 47 (Suppl): A211.

    Google Scholar 

  53. Sanhai WR, Romero LF, Hickey G, Ruttle D, Christenson RH. Performance characteristics of a revised cardiac troponin I assay for the Opus plus immunoassay system. Clin Biochem 2001; 34: 579–582.

    Article  PubMed  CAS  Google Scholar 

  54. Altinier S, Mion M, Cappelletti C, Zaninotto M, Plebani M. Rapid measurement of cardiac markers on Stratus CS. Clin Chem 2000; 46: 991–993.

    PubMed  CAS  Google Scholar 

  55. Kao JT, Wong IL, Lee JY, Chen RC. Comparison of Abbott AxSYM, Behring Opus Plus, DPC Immulite and Ortho-Clinical Diagnostics Vitros ECi for measurement of cardiac troponin I. Ann Clin Biochem 2001; 38: 140–146.

    Article  PubMed  CAS  Google Scholar 

  56. Apple FS, Anderson FP, Collinson P, et al. Clinical evaluation of the First Medical whole blood, point-of-care testing device for detection of myocardial infarction. Clin Chem 2000; 46: 1604–1609.

    PubMed  CAS  Google Scholar 

  57. Apple FS, Koplen B, Murakami MM. Preliminary evaluation of the Vitros ECi cardiac troponin I assay. Clin Chem 2000; 46: 572–574.

    PubMed  CAS  Google Scholar 

  58. Muller-Bardorff M, Rauscher T, Kampmann M, et al. Quantitative bedside assay for cardiac troponin T: a complementary method to centralized laboratory testing. Clin Chem 1999; 45: 1002–1008.

    PubMed  CAS  Google Scholar 

  59. Pagani F, Bonetti G, Panteghini M. Evaluation of the Elecsys electrochemiluminescent immunoassay for cardiac troponin T determination. Clin Chem. 1999; 45 (Suppl): A144.

    Google Scholar 

  60. Jaffe AS, Ravkilde J, Roberts R, et al. It’s time for a change to a troponin standard. Circulation 2000; 102: 1216–1220.

    Article  PubMed  CAS  Google Scholar 

  61. Panteghini M. Recent approaches in standardization of cardiac markers. Clin Chim Acta 2001; 311: 19–25.

    Article  PubMed  CAS  Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2003 Springer Science+Business Media New York

About this chapter

Cite this chapter

Panteghini, M. (2003). Standardization of Cardiac Markers. In: Wu, A.H.B. (eds) Cardiac Markers. Pathology and Laboratory Medicine. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-385-9_13

Download citation

  • DOI: https://doi.org/10.1007/978-1-59259-385-9_13

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-61737-319-0

  • Online ISBN: 978-1-59259-385-9

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics