Multicenter evaluation of analytical performance of the Liaison® troponin I assay

Clinical Biochemistry

Volumn 37, Issue 9, 2004, Pages 750-757

  Pagani, Franca ^a   Stefini, Francesca ^a   Chapelle, Jean Paul ^b   Lefèvre, Guillaume ^c   Graïne, Hanafi ^c   Luthe, Hilmar ^d   Engelmayer, Jutta ^d   Panteghini, Mauro ^a  

^a SPEDALI CIVILI   (Italy)

^b UNIVERSITY OF LIÈGE   (Belgium)

^c HÔPITAL TENON   (France)

^d UNIVERSITY OF GÖTTINGEN   (Germany)

Author keywords

Immunoassay; Myocardial infarction; Reference values; Troponin I

Indexed keywords

TROPONIN I;

ACCURACY; ADULT; AGED; ANTIBODY DETECTION; ANTIBODY SPECIFICITY; CONFERENCE PAPER; CONTROLLED STUDY; DYNAMICS; FEMALE; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; MALE; NORMAL HUMAN; PRIORITY JOURNAL; REFERENCE VALUE; SERUM; STATISTICAL SIGNIFICANCE;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; IMMUNOASSAY; LINEAR MODELS; MALE; MIDDLE AGED; STATISTICS, NONPARAMETRIC; TROPONIN I;

EID: 4344618004     PISSN: 00099120     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2004.04.003     Document Type: Conference Paper

References (25)

1. Jaffe A.S., Ravkilde J., Roberts R., et al. It's time for a change to a troponin standard. Circulation. 102:2000;1216-1220
2. Panteghini M. Acute coronary syndrome. Biochemical strategies in the troponin era. Chest. 122:2002;1428-1435
3. Alpert J., Thygesen K. For the Joint European Society of Cardiology/American College of Cardiology Committee Myocardial infarction redefined - A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J. Am. Coll. Cardiol. 36:2000;959-969
4. Panteghini M. Performance of today's cardiac troponin assays and tomorrow's. Clin. Chem. 48:2002;809-810
5. Panteghini M. The measurement of cardiac markers. Where should we focus? Am. J. Clin. Pathol. 118:2002;354-361
6. Powers D.M., Greenberg N. Development and use of analytical quality specifications in the in vitro diagnostics medical device industry. Scand. J. Clin. Lab. Invest. 59:1999;539-544
7. Panteghini M., Gerhardt W., Apple F.S., Dati F., Ravkilde J., Wu A.H. Quality specifications for cardiac troponin assays. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). IFCC Scientific Division Committee on Standardization of Markers of Cardiac Damage. Clin. Chem. Lab. Med. 39:2001;174-178
8. Liu S., Zhang M.Y., Song Q., Ling M., Kadijevic L., Shi Q. Recombinant single chain cardiac troponin I-C polypeptides: superior calibration and control materials for cardiac troponin I immunoassays. Clin. Lab. 47:2001;19-27
9. Burnett R.W. Quantitative evaluation of linearity. Clin. Chem. 26:1980;644-646
10. NCCLS Approved Guideline EP5-A Evaluation of precision performance of clinical chemistry devices. 1999;National Committee for Clinical Laboratory Standards, Wayne (PA)
11. Uettwiller-Geiger D., Wu A.H.B., Apple F.S., et al. Multicenter evaluation of an automated assay for troponin I. Clin. Chem. 48:2002;869-876
12. PetitClerc C., Solberg H.E. IFCC approved recommendation (1987) on the theory of reference values. Part 2. Selection of individuals for the production of reference values. J. Clin. Chem. Clin. Biochem. 25:1987;639-644
13. Ismail A.A.A., Walker P.L., Barth J.H., Lewandowski K.C., Jones R., Burr W.A. Wrong biochemistry results: two case reports and observational study in 5310 patients on potentially misleading thyroid-stimulating hormone and gonadotropin immunoassay results. Clin. Chem. 48:2002;2023-2029
14. Liaison® Troponin I - Ref. 315.101. Instructions for use. DiaSorin S.p.A. Released September 15, 2003.
15. Panteghini M., Pagani F., Yeo K.T.J., et al. Evaluation of imprecision for cardiac troponin assays at low-range concentrations. Clin. Chem. 50:2004;327-332
16. Apple F.S., Wu A.H.B. Myocardial infarction redefined: role of cardiac troponin testing. Clin. Chem. 47:2001;377-379
17. Apple F.S., Wu A.H., Jaffe A.S. European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction: how to use existing assays clinically and for clinical trials. Am. Heart J. 144:2002;981-986
18. Sheehan P., Blennerhassett J., Vasikaran S.D. Decision limit for troponin I and assay performance. Ann. Clin. Biochem. 39:2002;231-236
19. Venge P., Johnston N., Lagerqvist B., Wallentin L., Lindahl B. Clinical and analytical performance of the Liaison cardiac troponin I assay in unstable coronary artery disease, and the impact of age on the definition of reference limits. A FRISC-II substudy. Clin. Chem. 49:2003;880-886
20. Ferguson J.L., Beckett G.J., Stoddart M., Walker S.W., Fox K.A.A. Myocardial infarction redefined: the new ACC/ESC definition, based on cardiac troponin, increases the apparent incidence of infarction. Heart. 88:2002;343-347
21. Baum H., Brothag A., Hafner G., et al. Analytical evaluation of the Liaison® troponin I assay. Clin. Chem. 48:2002;A83
22. Panteghini M., Apple F.S., Christenson R.H., Dati F., Mair J., Wu A.H. Use of biochemical markers in acute coronary syndromes. IFCC Scientific Division, Committee on Standardization of Markers of Cardiac Damage. Clin. Chem. Lab. Med. 37:1999;687-693
23. Dorizzi R.M., Ferrari A., Caputo M. Troponin I measurement in heparin plasma and in serum. Clin. Chem. 48:2002;A90
24. Gerhardt W., Nordin G., Herbert A.K., et al. Troponin T and I assays show decreased concentrations in heparin plasma compared with serum: lower recoveries in early than in late phases of myocardial injury. Clin. Chem. 46:2000;817-821
25. Speth M., Seibold K., Katz N. Interaction between heparin and cardiac troponin T and troponin I from patients after coronary bypass surgery. Clin. Biochem. 35:2002;355-362