Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: Results of an IFCC pilot project

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 5, 2015, Pages 677-690

  Tate, Jillian R ^a   Bunk, David M ^b   Christenson, Robert H ^c   Barth, Julian H ^d   Katrukha, Alexey ^e   Noble, James E ^f   Schimmel, Heinz ^g   Wang, Lili ^b   Panteghini, Mauro ^h  

^a ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^b NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY   (United States)

^c UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^d LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^e HyTest Ltd   (Finland)

^f NATIONAL PHYSICAL LABORATORY   (United Kingdom)

^g JOINT RESEARCH CENTRE   (Italy)

^h UNIVERSITY OF MILAN   (Italy)

Author keywords

cardiac troponin I; certified reference material; standardization

Indexed keywords

TROPONIN I;

ACUTE HEART INFARCTION; ARTICLE; ASSAY; CALIBRATION; CORRELATION ANALYSIS; DIAGNOSTIC KIT; EVALUATION STUDY; HUMAN; INTERMETHOD COMPARISON; LIMIT OF DETECTION; MAJOR CLINICAL STUDY; MATHEMATICAL MODEL; MEASUREMENT; PRIORITY JOURNAL; STANDARDIZATION; ADOLESCENT; BLOOD; BLOOD ANALYSIS; FEMALE; HEART MUSCLE; METABOLISM; PILOT STUDY; STANDARD; STANDARDS; YOUNG ADULT;

ADOLESCENT; BLOOD CHEMICAL ANALYSIS; CALIBRATION; FEMALE; HUMANS; MYOCARDIUM; PILOT PROJECTS; REFERENCE STANDARDS; TROPONIN I; YOUNG ADULT;

EID: 84928041319     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2014-1197     Document Type: Article

References (30)

1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD: the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third Universal Definition of Myocardial Infarction. Circulation 2012;126:2020-35.
2. Global Harmonization Task Force (GHTF) Principles of IVD medical devices classification. Available from: http://www.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n045r12-in-vitro-diagnostic-classification-070209.pdf. Accessed 13 March, 2014.
3. ISO 17511:2003: In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials.
4. Christenson RH, Duh SH, Apple FS, Bodor GS, Bunk DM, Dalluge J, et al. Standardization of cardiac troponin I assays: round robin of ten candidate reference materials. Clin Chem 2001;47:471-7.
5. Bunk DM, Welch MJ. Characterization of a new certified reference material for human cardiac troponin I. Clin Chem 2006;52:212-9.
6. Christenson RH, Duh SH, Apple FS, Bodor GS, Bunk DM, Dalluge J, et al. Towards standardization of cardiac troponin I measurements. Part II: Assessing commutability of candidate reference materials and harmonization of cardiac troponin I assays. Clin Chem 2006;52:1685-92.
7. Dati F, Panteghini M, Apple FS, Christenson RH, Mair J, Wu AH. Proposals from 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):113-23.
8. Panteghini M. Current concepts in standardization of cardiac marker immunoassays. Clin Chem Lab Med 2004;42:3-8.
9. Panteghini M. Standardization of cardiac troponin I measurements: the way forward? Clin Chem 2005;51:1594-7.
10. Zegers I, Keller T, Schreiber W, Sheldon J, Albertini R, Blirup- Jensen S, et al. Characterization of the new serum protein reference material ERM-DA470k/IFCC: value assignment by immunoassay. Clin Chem 2010;56:1880-8.
11. Katrukha A, Bereznikova A, Pettersson K. New approach to standardization of human cardiac troponin I (cTnI). Scand J Clin Lab Invest 1999;59(Suppl 230):124-7.
12. Tate JR, Heathcote D, Koerbin G, Thean G, Andriske D, Bonar J, et al. The harmonization of cardiac troponin I measurement is independent of sample time collection but is dependent on the source of calibrator. Clin Chim Acta 2002;324:13-23.
13. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 1: Thyroid-stimulating hormone. Clin Chem 2010;56:902-11.
14. Eriksson S, Ilva T, Becker C, Lund J, Porela P, Pulkki K, et al. Comparison of cardiac troponin I immunoassays variably affected by circulating autoantibodies. Clin Chem 2005;51:848-55.
15. Tate JR. Troponin revisited 2008: assay performance. Clin Chem Lab Med 2008;46:1489-500.
16. IFCC Troponin table. Available from: http://www.ifcc.org/media/245202/IFCC%20Troponin%20I%20and%20T%20%28ng-L%20units%29-%20update%20December%202013.pdf; Accessed January, 2014.
17. Panteghini M. Selection of antibodies and epitopes for cardiac troponin immunoassays: should we revise our evidence-based beliefs? [editorial]. Clin Chem 2005;51:803-4.
18. Katrukha AG, Bereznikova AV, Filatov VL, Esakova TV, Kolosova OV, Pettersson K, et al. Degradation of cardiac troponin I: implication for reliable immunodetection. Clin Chem 1998;44:2433-40.
19. 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). Clin Chem Lab Med 2001;39:174-8.
20. Katrukha AG, Bereznikova AV, Esakova TV, Petterson K, Lövgren T, Severina ME, et al. Troponin I is released in bloodstream of patients with acute myocardial infarction not in free form but as complex. Clin Chem 1997;43:1379-85.
21. Panteghini M. Assay-related issues in the measurement of cardiac troponins. Clin Chim Acta 2009;402:88-93.
22. Wu AH, Lu AQ, Todd J, Moecks J, Wians F. Short- and long-term biological variation in cardiac troponin I measured with a highsensitivity assay: implications for clinical practice. Clin Chem 2009;55:52-8.
23. Panteghini M. Quality requirements for troponin assays - an overview. In: Laboratory and clinical issues affecting the measurement and reporting of cardiac troponins: a guide for clinical laboratories, 2012, The Australasian Association of Clinical Biochemists Inc., 2012:53-61.
24. Ungerer JP, Marquart L, O'Rourke PK, Wilgen U, Pretorius CJ. Concordance, variance, and outliers in 4 contemporary cardiac troponin assays: implications for harmonization. Clin Chem 2012;58:274-83.
25. Wu AH, Feng YJ, Moore R, Apple FS, McPherson PH, Buechler KF, et al. Characterization of cardiac troponin subunit release into serum after acute myocardial infarction and comparison of assays for troponin T and I. Clin Chem 1998;44:1198-208.
26. Eriksson S, Halenius H, Pulkki K, Hellman J, Pettersson K. Negative interference in cardiac troponin I immunoassays by circulating troponin autoantibodies. Clin Chem 2005;51:839-47.
27. Adamczyk M, Brashear RJ, Mattingly PG. Circulating cardiac troponin-I autoantibodies in human plasma and serum. Ann N Y Acad Sci 2009;1173:67-74.
28. Pettersson K, Eriksson S, Wittfooth S, Engström E, Nieminen M, Sinisalo J. Autoantibodies to cardiac troponin associate with higher initial concentrations and longer release of troponin I in acute coronary syndrome patients. Clin Chem 2009;55:938-45.
29. th percentile for clinical decision-making. Clin Chem 2009;55:85-92.
30. Venge P, Lindahl B. Cardiac troponin assay classification by both clinical and analytical performance characteristics: A study on outcome prediction. Clin Chem 2013;59:976-81.