Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population

Clinical Chemistry and Laboratory Medicine

Volumn 50, Issue 5, 2012, Pages 871-878

  Koerbin, Gus ^a,b   Tate, Jill ^c   Potter, Julia M ^a,d   Cavanaugh, Juleen ^d,e   Glasgow, Nicholas ^d   Hickman, Peter E ^a,d  

^a CANBERRA HOSPITAL   (Australia)

^b UNIVERSITY OF CANBERRA   (Australia)

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

^d The Australian National University   (Australia)

^e AUSTRALIAN NATIONAL UNIVERSITY   (Australia)

Author keywords

99th percentile; Health; Highly sensitive troponin I; Imprecision; Reference interval

Indexed keywords

HEMOGLOBIN; TROPONIN I;

ADULT; AGED; ARTICLE; CARDIOVASCULAR SYSTEM EXAMINATION; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; FEMALE; HEMOLYSIS; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; MALE; NORMAL HUMAN; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; PROTEIN DETERMINATION; PROTEIN EXPRESSION; SEX DIFFERENCE;

ADULT; AGED; AGED, 80 AND OVER; BLOOD CHEMICAL ANALYSIS; FEMALE; HEALTH; HEMOLYSIS; HUMANS; MALE; MIDDLE AGED; SEX FACTORS; TROPONIN I; YOUNG ADULT;

EID: 84867774889     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2011-0540     Document Type: Article

References (38)

1. Thygesen K, Alpert JS, White HD. On behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the redefinition of myocardial infarction. Universal definition of myocardial infarction. Eur Heart J 2007;28:2525-38.
2. Kavsak PA, Macrae AR, Yerna MJ, Jaffe AS. Analytic and clinical utility of a next-generation, highly sensitive cardiac troponin I assay for early detection of myocardial injury. Clin Chem 2009;55:573-7.
3. Giannitsis E, Kurz K, Hallermayer K, Jarausch J, Jaffe AS, Katus HA. Analytical variation of a high-sensitivity cardiac troponin T assay. Clin Chem 2010;56:254-61.
4. Apple FS. High-sensitivity cardiac troponin for screening large populations of healthy people: is there risk ? Clin Chem 2011;57:537-9.
5. Hickman PE, Koerbin G, Southcott E, Tate J, Dimeski G, Carter A, et al. Newer cardiac troponin I assays have similar performance to troponin T in patients with end-stage renal disease. Ann Clin Biochem 2007;44:285-9.
6. Tate JR, Ferguson W, Bais R, Kostner K, Marwick T, Carter A. The determination of the 99th centile level for troponin assays in an Australian reference population. Ann Clin Biochem 2008;45:275-88.
7. Baggish AL, Cameron R, Anwaruddin S, Chen AA, Krauser DG, Tung R, et al. A clinical and biochemical critical pathway for the evaluation of patients with suspected acute congestive heart failure: The ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) algorithm. Crit Pathw Cardiol 2004;3:171-6.
8. Royal College of Pathologists of Australasia. RCPA Manual [internet] 2009. Available from: http://www.rcpamanual.edu.au/index.php?option=com- pdst&task=show-pdst&id=50&Itemid=79. [Accessed 2011, September 17].
9. Koerbin G, Tate JR, Hickman PE. Analytical characteristics of the Roche highly sensitive troponin T assay and its application to a cardio-healthy population. Ann Clin Biochem 2010;47:524-8.
10. McGill D, Talaulikar G, Potter JM, Koerbin G, Hickman PE. Over time, high-sensitivity TnT replaces NT-proBNP as the most powerful predictor of death in patients with dialysis-dependent chronic renal failure. Clin Chim Acta 2010;411:936-9.
11. Kavsak PA, Xu L, Yusuf S, McQueen MJ. High-sensitivity cardiac troponin I measurement for risk stratification in a stable high-risk population. Clin Chem 2011;57:1146-53.
12. Tholen DW, Linnet K, Kondratovich M, Armbruster DA, Garrett PE. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. EP17-A 2004a; Vol. 24 No. 34.
13. Panteghini M. Assay-related issues in the measurement of cardiac troponins. Clin Chim Acta 2009;402:88-93.
14. Wu AHB, Lu AQ, Todd J, Moecks J, Wians F. Short-and long-term biological variation in cardiac troponin I measured with a high-sensitivity assay: implications for clinical practice. Clin Chem 2009;55:52-8
15. Tholen DW, Kallner A, Kennedy JW, Krouwer JS, Meier K. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition 2004b; Volume 24 Number 25 EP5-A2.
16. Sadler WA. Imprecision profiling. Clin Biochem Rev 2008;29(Suppl 1):S33-6.
17. Tholen DW, Kroll M, Astles JR, Caffo AL, Happe TM, Krouwer JS, et al. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline 2003 Volume 23 Number 16 EP6-A.
18. Tholen DW. Evaluation of Linearity Using the Newly Approved NCCLS EP6-A Protocol. Clin Lab News Jan; 2004:10-2.
19. Dimeski G, Clague AE, Hickman PE. Correction and reporting of potassium results in haemolysed samples. Ann Clin Biochem 2005;42:119-23.
20. Apple FS, Simpson PA, Murakami MM. Defining the serum 99th percentile in a normal reference population measured by a high-sensitivity cardiac troponin I assay. Clin Biochem 2010;43:1034-6.
21. 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 Society of Cardiology/American College of Cardiology/American Heart Association/World Heart Federation Task Force for the Definition of Myocardial Infarction. Clin Chem 2010;56:941-3.
22. Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, et al. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J 2010;31:2197-204.
23. Badrick T, Wilson SR, Dimeski G, Hickman PE. Objective determination of appropriate reporting intervals. Ann Clin Biochem 2004;41:385-90.
24. Apple FS. A new season for cardiac troponin assays: it's time to keep a scorecard. Clin Chem 2009;55:1303-6.
25. Clerico A, Fortunato A, Ripoli A, Prontera C, Zucchelli GC, Emdin M. Distribution of plasma cardiac troponin I values in healthy subjects: physiological considerations. Clin Chem Lab Med 2008;46:804-8.
26. Bergmann O, Bhardwaj R, Bernard S, Zdunek S, Barnabé-Heider F, Walsh S, et al. Evidence for cardiac myocte renewal in humans. Science 2009;324:98-102.
27. Venge P, Johnston N, Lindahl B, James S. Normal plasma levels of cardiac troponin I measured by the high-sensitivity cardiac tro-ponin I Access prototype assay and the impact on the diagnosis of myocardial ischemia. J Am Coll Cardiol 2009;54:1165-72.
28. Mingels A, Jacobs L, Michielsen E, Swaanenburg J, Wodzig W, Van Dieijen-Visser M. Reference population and marathon runner sera assessment by highly sensitive troponin T and commercial cardiac troponin T and I assays. Clin Chem 2009;55:101-8.
29. Sabatine MS, Morrow DA, De Lemos JA, Jarolim P, Braunwald E. Detection of acute changes in circulating troponin in the setting of transient stress-induced myocardial ischemia using an ultrasensitive assay: results from TIMI 35. Eur Heart J 2009;30:162-9.
30. Hickman PE, Potter JM, Aroney C, Koerbin G, Southcott E, Wu AH, et al. Cardiac troponin may be released by ischemia alone, without necrosis. Clin Chim Acta 2010;411:318-23.
31. Turer AT, Addo TA, Martin JL, Sabatine MS, Lewis GD, Gerszten RE, et al. Myocardial ischemia induced by rapid atrial pacing causes troponin T release detectable by a highly sensitive assay. J Am Coll Cardiol 2011;57:2398-405.
32. De Lemos JA, Drazner MH, Omland T, Ayers CR, Khera A, Rohatgi A, et al. Association of troponin T detected with a highly sensitive assay and cardiac structure and mortality risk in the general population. J Am Med Assoc 2010;304:2503-12.
33. De Filippi CR, De Lemos JA, Christenson RH, Gottdiener JS, Kop WJ, Zhan M, et al. Association of serial measures of cardiac troponin T using a sensitive assay with incident heart failure and cardiovascular mortality in older adults. J Am Med Assoc 2010;304:2494-2502.
34. Saunders JT, Nambi V, De Lemos JA, Chambless LE, Virani SS, Boerwinkle E, et al. Cardiac troponin T measured by a highly sensitive assay predicts coronary heart disease, heart failure, and mortality in the Atherosclerosis Risk in Communities Study. Circulation 2011;123:1367-76.
35. Muller-Bardorf M, Weidtmann B, Giannitsis E, Kurowski V, Katus HA. Release kinetics of cardiac troponin T in survivors of confirmed severe pulmonary embolism. Clin Chem 2002;48:673-5.
36. Reichlin T, Irfan A, Twerenbold R, Reiter M, Hochholzer W, Burkhalter H, et al. Utility of absolute and relative changes in cardiac troponin concentrations in the early diagnosis of acute myocardial infarction. Circulation 2011;124:136-45.
37. Aldous SJ, Richards AM, Cullen L, Than MP. Early dynamic change in high-sensitivity cardiac troponin T in the investigation of acute myocardial infarction. Clin Chem 2011;57:1154-60.
38. Vasile VC, Saenger AK, Kroning JM, Jaffe AS. Biological and analytical variability of a novel high-sensitivity cardiac troponin T assay. Clin Chem 2010;56:1086-90.