A practical approach for the validation and clinical implementation of a high-sensitivity cardiac troponin I assay across a North American city

Practical Laboratory Medicine

Volumn 1, Issue 1, 2015, Pages 28-34

  Kavsak, Peter A ^a,b,c   Beattie, John ^c,d   Pickersgill, Robin ^c,e   Ford, Lynn ^c,f   Caruso, Nadia ^c,d   Clark, Lorna ^b,c  

^a MCMASTER UNIVERSITY   (Canada)

^b HAMILTON HEALTH SCIENCES   (Canada)

^c Hamilton General Hospital ^*  (Canada)

^d HAMILTON GENERAL HOSPITAL   (Canada)

^e ST JOSEPH S HOSPITAL   (Canada)

^f MCMASTER CHILDREN S HOSPITAL   (Canada)

Author keywords

High sensitivity cardiac troponin; Implementation; Multicenter; Quality; Validation

Indexed keywords

EID: 84938702734     PISSN: None     EISSN: 23525517     Source Type: Journal    
DOI: 10.1016/j.plabm.2015.02.001     Document Type: Article

References (34)

1. Kavsak P.A. Early standardization of high sensitivity troponin T reporting - a lost opportunity. Clin Biochem 2011, 44:758-759.
2. High-sensitivity cardiac troponin for the rapid diagnosis of acute coronary syndrome in the emergency department: a clinical and cost-effectiveness evaluation [Internet]. Source: Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; March 2013. http://www.cadth.ca/en/products/optimal-use/%20high-sensitivity-troponin.
3. Kavsak P.A., Jaffe A.S., Hickman P.E., Mills N.L., Humphries K.H., McRae A., et al. Canadian Institutes of Health Research dissemination grant on high-sensitivity cardiac troponin. Clin Biochem 2014, 47:155-157.
4. Kavsak P.A., Allen L.C., Apple F.S., Booth R.A., Chan P.C., Delvin 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, 44:1273-1277.
5. Apple F.S., Collinson P.O. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem 2012, 58:54-61. IFCC Task Force on Clinical Applications of Cardiac Biomarkers.
6. Apple F.S., Jaffe A.S., Collinson P., Mockel M., Ordonez-Llanos J., Lindahl B., et al. IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays. Clin Biochem 2015, 48:201-203.
7. Giannitsis E., Kurz K., Hallermayer K., Jarausch J., Jaffe A.S., Katus H.A. Analytical validation of a high-sensitivity cardiac troponin T assay. Clin Chem 2010, 56:254-261.
8. Koerbin G., Tate J., Potter J.M., Cavanaugh J., Glasgow N., Hickman P.E. Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population. Clin Chem Lab Med 2012, 50:871-878.
9. Saenger A.K., Beyrau R., Braun S., Cooray R., Dolci A., Freidank H., et al. Multicenter analytical evaluation of a high-sensitivity troponin T assay. Clin Chim Acta 2011, 412:748-754.
10. Krintus M., Kozinski M., Boudry P., Capell N.E., Köller U., Lackner K., et al. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay. Clin Chem Lab Med 2014, 52:1657-1665.
11. Kavsak P.A., MacRae A.R., Yerna M.J., Jaffe A.S. Analytic and clinical utility of a next-generation, highly sensitive cardiac troponin I assay for early detection of myocardial injury. Clin Chem 2009, 55:573-577.
12. Reichlin T., Hochholzer W., Bassetti S., Steuer S., Stelzig C., Hartwiger S., et al. Early diagnosis of myocardial infarction with sensitive cardiac troponin assays. N Engl J Med 2009, 361:858-867.
13. Keller T., Zeller T., Ojeda F., Tzikas S., Lillpopp L., Sinning C., et al. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. J Am Med Assoc 2011, 306:2684-2693.
14. Kavsak P.A., Shortt C., Pond G., Worster A. High-sensitivity cardiac troponin I for predicting death in a female emergency department population. Clin Chem 2014, 60:271-273.
15. Kavsak P.A. Quality control material testing and the importance of treating it like a patient's sample. Clin Biochem 2014, 47:147-149.
16. Kavsak P.A., Caruso N., Beattie J., Clark L. Centrifugation-an important pre-analytical factor for the Abbott Architect high-sensitivity cardiac troponin I assay. Clin Chim Acta 2014, 436:273-275.
17. Kavsak P.A., Clark L., Lancaster S., Don-Wauchope A.C. Within-run precision and outlier detection for the Abbott ARCHITECT cardiac troponin I assay. Ann Clin Biochem 2014, 51:512-514.
18. Kavsak P.A. Highly sensitive cardiac troponin T assay, cardiac disease, and mortality risk. J Am Med Assoc 2011, 305:1196.
19. Rezvanpour A., Shortt C., Clark L., Worster A., Kavsak P.A. Analytical factors to consider when assessing a high-sensitivity cardiac troponin I assay compared to a contemporary assay in clinical studies. Clin Chim Acta 2014, 429:6-7.
20. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology 2014, 120:564-578. Vascular events In noncardiac Surgery patIents cOhort evaluatioN VISION Study Investigators.
21. Omland T., de Lemos J.A., Sabatine M.S., Christophi C.A., Rice M.M., Jablonski K.A., et al. A sensitive cardiac troponin T assay in stable coronary artery disease. N Engl J Med 2009, 361:2538-2547.
22. deFilippi C.R., de Lemos J.A., Christenson R.H., Gottdiener J.S., Kop W.J., 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.
23. Saunders J.T., Nambi V., de Lemos J.A., Chambless L.E., Virani S.S., 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, 123:1367-1376.
24. Kavsak P.A., Xu L., Yusuf S., McQueen M.J. High-sensitivity cardiac troponin I measurement for risk stratification in a stable high-risk population. Clin Chem 2011, 57:1146-1153.
25. McQueen M.J., Kavsak P.A., Xu L., Shestakovska O., Yusuf S. Predicting myocardial infarction and other serious cardiac outcomes using high-sensitivity cardiac troponin T in a high-risk stable population. Clin Biochem 2013, 46(1-2):5-9.
26. Omland T., Pfeffer M.A., Solomon S.D., de Lemos J.A., Røsjø H., Šaltyte Benth J., et al. Prognostic value of cardiac troponin I measured with a highly sensitive assay in patients with stable coronary artery disease. J Am Coll Cardiol 2013, 61:1240-1249.
27. Zeller T., Tunstall-Pedoe H., Saarela O., Ojeda F., Schnabel R.B., Tuovinen T., et al. High population prevalence of cardiac troponin I measured by a high-sensitivity assay and cardiovascular risk estimation: the MORGAM Biomarker Project Scottish Cohort. Eur Heart J 2014, 35:271-281.
28. McKie P.M., AbouEzzeddine O.F., Scott C.G., Mehta R., Rodeheffer R.J., Redfield M.M., et al. High-sensitivity troponin i and amino-terminal Pro-B-type natriuretic peptide predict heart failure and mortality in the general population. Clin Chem 2014, 60:1225-1233.
29. Body R., Carley S., McDowell G., Jaffe A.S., France M., Cruickshank K., et al. Rapid exclusion of acute myocardial infarction in patients with undetectable troponin using a high-sensitivity assay. J Am Coll Cardiol 2011, 58:1332-1339.
30. Bandstein N., Ljung R., Johansson M., Holzmann M.J. Undetectable high-sensitivity cardiac troponin T level in the emergency department and risk of myocardial infarction. J Am Coll Cardiol 2014, 63:2569-2578.
31. Shortt C., Phan K., Hill S.A., Worster A., Kavsak P.A. An approach to rule-out an acute cardiovascular event or death in emergency department patients using outcome-based cutoffs for high-sensitivity cardiac troponin assays and glucose. Clin Biochem 2015, 48:282-287.
32. Kavsak P.A., Hill S.A., McQueen M.J., Devereaux P.J. Implications of adjustment of high-sensitivity cardiac troponin T assay. Clin Chem 2013, 59(3):574-576.
33. Simpson A.J., Potter J.M., Koerbin G., Oakman C., Cullen L., Wilkes G.J., et al. Use of observed within-person variation of cardiac troponin in emergency department patients for determination of biological variation and percentage and absolute reference change values. Clin Chem 2014, 60:848-854.
34. Kavsak P.A., Worster A., You J.J., Oremus M., Shortt C., Phan K., et al. Ninety-minute vs 3-h performance of high-sensitivity cardiac troponin assays for predicting hospitalization for acute coronary syndrome. Clin Chem 2013, 59:1407-1410.