Improving the 510(k) FDA process for cardiac troponin assays: In search of common ground

Clinical Chemistry

Volumn 60, Issue 10, 2014, Pages 1273-1275

  Apple, Fred S ^a,b   Hollander, Judd ^c   Wu, Alan H B ^d   Jaffe, Allan S ^e  

^a HENNEPIN COUNTY MEDICAL CENTER   (United States)

^b UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^c THOMAS JEFFERSON UNIVERSITY   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; TROPONIN;

ACUTE CORONARY SYNDROME; ACUTE HEART INFARCTION; CARDIAC TROPONIN ASSAY; CLINICAL PROTOCOL; ELECTROCARDIOGRAM; FEEDBACK SYSTEM; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HUMAN; LEADERSHIP; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PRACTICE GUIDELINE; PROTEIN DETERMINATION; QUALITY CONTROL; QUESTIONNAIRE; REFERENCE VALUE; REVIEW; BLOOD; BLOOD ANALYSIS; CLINICAL CHEMISTRY; HEART DISEASE; LEGISLATION AND JURISPRUDENCE; PROCEDURES; STANDARDS; UNITED STATES;

BLOOD CHEMICAL ANALYSIS; CHEMISTRY, CLINICAL; HEART DISEASES; HUMANS; LIMIT OF DETECTION; PRACTICE GUIDELINES AS TOPIC; TROPONIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84921775429     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2014.229286     Document Type: Review

References (15)

1. Collinson PO, Heung YM, Gaze D, Boa F, Senior R, Christenson R, et al. Influence of population selection on the 99th percentile reference value for cardiac troponin assays. Clin Chem 2012;58:219-25.
2. Apple FS, Collinson PO, for the IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem 2012:58:54-61.
3. deLemos 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. JAMA 2010; 304: 2503-12.
4. Thygesen K, Johannes M, Katus H, Plebani M, Venge P, Collinson P, et al. The Study Group on Biomarkers in Cardiology of the ESC Working Group on Acute Cardiac Care. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J 2010;31:2197-204.
5. CLSI. Protocols for determination of limits of detection and limits of quantitation; approved guideline. Wayne (PA): CLSI; 2012. EP17-A.
6. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman R, White HD; 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. J Am Coll Card 2012;60:1581-98
7. Circulation 2012;126:2020-35
8. Eur Heart J 2012;33:2252-7.
9. Korley FK, Schulman SP, Sokoll LJ, Stolbach AI, deFilippi AP, Bayram JM, et al. Troponin elevations only detected with a high sensitivity assay: clinical correlations and prognostic significance. Acad Emerg Med 2014;21:727-35.
10. Pines JM, Pollack CV Jr, Diercks DB, Chang AM, Shofer FS, Hollander JE. The association between emergency department crowding and adverse cardiovascular outcomes in patients with chest pain. Acad Emerg Med 2009;16:617-25.
11. Cullen L, Miller C, Parsonage WA, Wildi K, Green-slade JH, Twerenbold R, et al. Validation of high-sensitivity troponin I in a 2-h diagnostic strategy to assess 30-day outcomes in emergency-department patients with possible acute coronary syndromes. J Am Coll Cardiol 2013;62:1242-9.
12. Korley FK, Jaffe AS. Preparing the United States for high-sensitivity cardiac troponin assays. J Am Coll Cardiol 2013;61:1753-8.
13. Jaffe AS, Moeckel M, Giannitsis E, Huber K, Mair J, Mueller C, et al. In search for the Holy Grail: suggestions for studies to define delta changes to diagnose or exclude acute myocardial infarction a position paper from the study group on bio-markers of the Acute Cardiovascular Care Association. Eur Heart J Acute Cardiovasc Care [Epub ahead of print 2014 Jul 9]
14. TropI: instructions for use. http://apps. orthoclinical.com//IFU/ContentPages/displayDoc. aspx?hidebanner=Y&cPath=TropIES-GEM1309- WW-EN-I.pdf (Accessed June 2014).
15. Hollander JE, Blomkalns AL, Brogan GX, Diercks DB, Field JM, Garvey JL, et al. Standardized reporting guidelines for studies evaluated risk stratification of ED patients with potential acute coronary syndromes. Ann Emerg Med 2004;44: 589-98.