Association for clinical chemistry and the task force on clinical applications of cardiac bio-Markers of the international federation of clinical chemistry and laboratory medicine

Clinical Chemistry

Volumn 64, Issue 4, 2018, Pages 645-655

  Wu, Alan H B ^a   Christenson, Robert H ^b   Greene, Dina N ^c   Jaffe, Allan S ^d   Kavsak, Peter A ^e   Ordonez Llanos, Jordi ^f   Apple, Fred S ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

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

^c UNIVERSITY OF WASHINGTON   (United States)

^d MAYO CLINIC   (United States)

^e MCMASTER UNIVERSITY   (Canada)

^f UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^g UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; TROPONIN I; TROPONIN T;

ACUTE CORONARY SYNDROME; BLOOD; CLINICAL CHEMISTRY; CLINICAL LABORATORY SERVICE; HUMAN; INTERNATIONAL COOPERATION; PRACTICE GUIDELINE; QUALITY CONTROL; STANDARD;

ACUTE CORONARY SYNDROME; BIOMARKERS; CLINICAL CHEMISTRY TESTS; CLINICAL LABORATORY SERVICES; HUMANS; INTERNATIONALITY; QUALITY CONTROL; REFERENCE STANDARDS; TROPONIN I; TROPONIN T;

EID: 85044673314     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2017.277186     Document Type: Article

References (63)

1. Wu AHB, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: recommendations for use of cardiac markers in coronary artery diseases. Clin Chem 1999;45:1104 –21.
2. Apple FS, Jesse RL, Newby LK, Wu AHB, Christenson RH. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: analytical issues for biochemical markers of acute coronary syndromes. Clin Chem 2007;53:547–51.
3. Apple FS,Wu AHB,Jaffe AS,Panteghini M,Christenson RH.NationalAcademyofClinicalBiochemistryandIFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine practice guidelines: analytical issues for biomarkers of heart failure. Circulation 2007;116:e95– 8.
4. Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AHB, Christenson RH. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Clin Chem 2007;53:552–74.
5. Tang WHW, Francis GS, Morrow DA, Newby LK, Cannon CP, Jesse RL, et al. National Academy of Clinical Biochemistry Laboratory Medicine practice guidelines: clinical utilization of cardiac biomarker testing in heart failure. Circulation 2007;116:e99 –109.
6. Wu AHB, Apple FS, Jaffe AS, Jesse RL, Morrow DA, Newby K, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: use of cardiac troponin and the natriuretic peptides for etiologies other than acute coronary syndromes and heart failure. Clin Chem 2007;53:2086 –96.
7. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Circulation 2012;126:2020 –35.
8. Thygesen K, Mair J, Giannitsis E, Mueller C, Lindahl B, Blankenberg S, et al. How to use high-sensitivity cardiac troponins in acute cardiac care. Eur Heart J 2012;33: 2252–57.
9. Amsterdam EA, Wenger NK, Brindis RG, Casey DE, Gani-ats TG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 130:2354 –94.
10. Apple FS, Jaffe AS, Collinson P, Mockel M, Ordonez-Llanos J, Lindahl B, et al. on behalf of the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers. IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays. Clin Biochem 2015;48:201–3.
11. Panteghini M. Assay-related issues in the measurement of cardiac troponins. Clin Chim Acta 2009;402: 88–93.
12. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016;37:267–315.
13. Lyon AW,Kavsak PA,Lyon OAS,Worster A,Lyon ME.Sim-ulationmodelsofmisclassificationerrorforsinglethresh-oldsofhigh-sensitivitycardiactroponinIduetoassaybias andimprecision.Clin Chem 2017;63:585–92.
14. st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5.
15. Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, et al. Criteria for assigning laboratory mea-surands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55:189 –94.
16. Kavsak PA, Jaffe AS, Greene DN, Christenson RH, Apple FS, Wu AHB. Total analytic error for low cardiac troponin concentrations (≤10 ng/L) by use of a high-sensitivity cardiac troponin assay. Clin Chem 2017;63:1043–5.
17. Tate J, Johnson R, Jaffe A, Panteghini M. Laboratory and clinical issues affecting the measurement and reporting of cardiac troponins: a guide for clinical laboratories. A monograph on cardiac troponin, produced by the AACB Scientific and Regulatory Affairs. Committee in collaboration with the AACB Publications team on behalf of the AACB Troponin Working Party. 2012, Aus-traliasian Association of Clinical Biochemists, 2012. Available from: http://www.aacb.asn.au/sitebuilder/products/files/26/troponinmonographa4flier26092012.pdf (Accessed 12/5/2017).
18. Thole DW, Linnet K, Kondratovich M, Armburster DA, Garrett PE, et al. Protocols for determination of limits of detection and limits of quantitation; approved guideline. Clin Lab Standards Institute. EP17-A 2004;24(34).
19. Apple FS, Hollander J, Wu AH, Jaffe AS. Improving the 510(k) FDA process for cardiac troponin assays: in search of common ground. Clin Chem 2014;60: 1273–5.
20. Jaffe AS, Apple FS, Morrow DA, Lindahl B, Katus HA. Being rational about (im)precision: a statement from the Biochemistry Subcommittee of the Joint European
21. Society of Cardiology/American College of Cardiology Foundation/American Heart Association/World Heart Federation Task Force for the definition of myocardial infarction. Clin Chem 2010;56:941–3.
22. Hammarsten O, Jacobsson CE, Widegren M, Danyl-chenko T,Jaffe AS.Long-timequalityassessmentofthe Elecsys Troponin T hs assay. Clin Biochem 2013;46: 1055–7.
23. Kavsak PA, Don-Wauchope AC, Hill SA, Worster A. Acceptable analytical variation May exceed high-sensitivity cardiac troponin I cutoffs in early rule-out and rule in acute myocardial infarction algorithms. Clin Chem 2016;62:887–9.
24. Kavsa k
25. Apple FS, Sandoval Y, Jaffe AS, Ordonez-Llanos J. IFCC Task Force on Clinical Applications of Cardiac Bio-Markers. Cardiac troponin assays: guide to understanding analytical characteristics and their impact on clinical care. Clin Chem 2017;63:73– 81.
26. Pierson-Perry JF, Vaks JE, Durham AP, Fischer C, Guten-brunner C, Hillyard D, Kondratovich MV. Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline, second edition. Clinical and Laboratory Standards Institute document EP17–A2, Wayne, PA: 2012.
27. Kavsak PA, Hill SA, McQueen MJ, Devereaux PJ. Implications of adjustment of high-sensitivity cardiac troponin T assay. Clin Chem 2013;59:574 – 6.
28. Kavsak PA, Allen LC, Apple FS, Booth RA, Chan PC, Del-vin E, et al. Cardiac troponin testing in the acute care setting: ordering, reporting, and high sensitivity assays—an update from the Canadian society of clinical chemists (CSCC). Clin Biochem 2011;44:1273–7.
29. Sandstede J,Lipke C,Beer M,Hofmann S,Pabst T,Kenn W,etal.Age-andgender-specificdifferencesinleftand rightventricularcardiacfunctionandmassdetermined bycinemagneticresonanceimaging.EurRadiol2000; 10:438–42.
30. Collinson PO, Heung YM, Gaze D, Boa F, Senior R, Christenson R, Apple FS. Influence of population selection on the 99th percentile reference value for cardiac troponin assays. Clin Chem 2012;58:219 –2.
31. Eggers KM, Lind L, Venge P, Lindahl B. Factors influencing the 99th percentile of cardiac troponin I evaluated in community-dwelling individuals at 70 and 75 years of age. Clin Chem 2013;59:1068 –73.
32. Gore MO, Seliger SL, Defilippi CR, Nambi V, Christenson RH, Hashim IA, et al. Age- and sex-dependent upper reference limits for the high-sensitivity cardiac troponin T assay. J Am Coll Cardiol 2014;63:1441– 8.
33. Sandoval Y, Apple FS. The global need to define normality: the 99th percentile value of cardiac troponin. Clin Chem 2013;60:455– 62.
34. Eggers KM,Apple FS,Lind L,Lindah lB.Theappliedstatis-ticalapproachhighlyinfluencesthe99thpercentileofcar-diactroponinI.ClinBiochem2016;49:1109–12.
35. Levey AS, Stevens UA, Schmid CH, Zhang Y, Castro AF, Feldman HT. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604 –12.
36. Selvin E,Laxo M,Chen Y,Shen L,Rubin J,McEvoy JW et al.Diabetesmellitus,prediabetesandincidenceofsub-clinical myocardial damage. Circulation 2014;130: 1374–82.
37. Hickman PE, Koerbin G, Potter JM, Abhayaratna WP. Statistical considerations for determining high-sensitivity cardiac troponin reference intervals. Clin Biochem 2017;50:502–5.
38. Shah ASV, Griffiths M, Lee KK, McAllister DA, Hunter AL, Ferry AV, et al. High sensitivity cardiac troponin and the under-diagnosis of myocardial infarction in women: prospective cohort study. BMJ 2015;350:gb7873.
39. Mueller-Hennessen M, Lindahl B, Giannitsis E, Biener M, Vafaie M, deFilippi CR, et al. Diagnostic and prognostic implications using age- and gender-specific cutoffs for high-sensitivity cardiac troponin T—sub-analysis from the TRAPID-AMI study. Int J Cardiol 2016;209: 26 –33.
40. Eggers KM,Lindah lB.Impactofsexoncardiactroponin concentrations- a critical appraisal. Clin Chem 2017; 63:1457–64.
41. Giannitsis E. Potential concerns regarding the use of sex-specific cutpoints for high-sensitivity troponin assays. Clin Chem 2017;63:264 – 6.
42. Cullen L, Greenslade JH, Carlton EW, Than M, Pickering JW, Ho A, et al. Sex-specific versus overall cut points for a high sensitivity troponin I assay in predicting 1-year outcomes in emergency patients presenting with chest pain. Heart 2016;102:120 – 6.
43. Sandoval Y, Smith SW, Thordsen SE, Bruen CA, Carlson MD, Dodd KW, et al. Diagnostic performance of high sensitivity compared to contemporary cardiac troponin I for the diagnosis of acute myocardial infarction. Clin Chem 2017;63:1594 –1604.
44. Sandoval Y, Smith SW, Apple FS. Present and future of high sensitivity cardiac troponin in clinical practice: a paradigm shift to high sensitivity assays. Am J Med 2016;129:354 – 65.
45. Bais R. The effect of sample hemolysis on cardiac troponin I and T assays. Clin Chem 2010;56:1357–9.
46. 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 –283.
47. Jaffe AS, Vasile VC, Milone M, Saenger AK, et al. Diseased skeletal muscle: a noncardiac source of increased circulating concentrations of cardiac troponin T. J Am Coll Cardiol 2011;58:1819 –24.
48. Panteghini M, Gerhardt W, Apple FS, Dati F, Ravkilde J, Wu AH. Quality specifications for cardiac troponin assays. Clin Chem Lab Med 2001;39:175–9.
49. Park JY, Jaffe AS. Troponin autoantibodies: from assay interferent to mediator of cardiotoxicity. Clin Chem 2017;63:30 –2.
50. Ungerer JP, Tate JR, Pretorius CJ. Discordance with 3 cardiac troponin I and T assays: implications for the 99th Percentile Cutoff. Clin Chem 2016;62:1106 –14.
51. Saenger AK,Haymond S.Utilizationofcardiactroponin assays in adult and pediatric populations: guideline recommendations vs. reality. Clin Biochem 2015;48: 1213–8.
52. Collinson P, Hammerer-Lercher A, Suvisaari J, Apple FS, Christenson RH, Pulkki K, et al. Working Group for Cardiac Markers, European Federation of Clinical Chemistry and Laboratory Medicine. How well do laboratories adhere to recommended clinical guidelines for the management of myocardial infarction: The CARdiac MArker Guidelines Uptake in Europe Study (CARMA-GUE). Clin Chem 2016;62:1264 –71.
53. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glas-ziou PP, Irwig L, et al. for the STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. Clin Chem 2015;61: 1446 –52.
54. Jaffe AS, Katus H. Acute coronary syndrome biomarkers: the need for more adequate reporting. Circulation 2004; 110:104 – 6.
55. Christenson RH, Duh SH, Apple F, Bodor G, Bunk D, Panteghini M, et al. Toward 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.
56. Christenson RH, Bunk DM, Schimmel H, Tate JR. Point: put simply, standardization of cardiac troponin I is complicated. Clin Chem 2012;58:165– 8.
57. Apple FS. Counterpoint: standardization of cardiac troponin I assays will not occur in my lifetime. Clin Chem 2012;58:169 –173.
58. Tate JR, Bunk DM, Christenson RH, Barth JH, Katrukha A, Noble JE et al. Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project. Clin Chem Lab Med 2015;53:677–90.
59. Panteghini M. Standardization of cardiac troponin I measurements: the way forward? Clin Chem 2005;51: 1594 –7.
60. Ferraro S, Dolci A, Panteghini M. Fast track protocols using highly sensitive troponin assays for ruling out and ruling in non-ST elevation acute coronary syndrome. Clin Chem Lab Med 2017;55(11):1683–9.
61. Cullen LA, Mills NL, Mahler S, Body R. Early rule-out and rule-in strategies for myocardial infarction. Clin Chem 2017;63:129 –39.
62. Wu AH. Biological and analytical variation of clinical biomarker testing: implications for biomarker-guided therapy. Curr Heart Fail Rep 2013;10:434 – 40.
63. Keller T,Zeller T,Ojeda F,Tzikas S,Lillpopp L,Sinning C, etal.SerialchangesinhighlysensitivetroponinIassay and early diagnosis of myocardial infarction. JAMA 2011;306:2684–93.