Evaluation of analytical performance and comparison of clinical results of the new generation method AccuTnI+3 for the measurement of cardiac troponin I using both patients and quality control plasma samples

Clinica Chimica Acta

Volumn 451, Issue , 2015, Pages 129-134

  Storti, Simona ^a   Masotti, Silvia ^b   Prontera, Concetta ^a   Franzini, Maria ^a,c   Buzzi, Paola ^d   Casagranda, Ivo ^d   Ciofini, Enrica ^b   Zucchelli, Gian Carlo ^e   Ndreu, Rudina ^e   Passino, Claudio ^a,b   Clerico, Aldo ^a,b  

^a CNR   (Italy)

^b SCUOLA SUPERIORE SANT ANNA   (Italy)

^c UNIVERSITY OF PISA   (Italy)

^d Santi Antonio e Biagio and Cesare Arrigo Hospital   (Italy)

^e INSTITUTE OF CLINICAL PHYSIOLOGY   (Italy)

Author keywords

Automated immunometric assays; Cardiac troponins; High sensitive methods; Myocardial infarction

Indexed keywords

TROPONIN I;

ANALYTICAL PARAMETERS; ARTICLE; CHEMOLUMINESCENCE; CONSENSUS; CONTROLLED STUDY; CORRELATION ANALYSIS; DIAGNOSTIC EQUIPMENT; DIAGNOSTIC TEST ACCURACY STUDY; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; LIMIT OF BLANK; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PERFORMANCE; PLASMA; PREDICTIVE VALUE; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; BLOOD; COMPARATIVE STUDY; EVALUATION STUDY; LUMINESCENCE;

HUMANS; IMMUNOASSAY; LUMINESCENT MEASUREMENTS; QUALITY CONTROL; TROPONIN I;

EID: 84952989335     PISSN: 00098981     EISSN: 18733492     Source Type: Journal    
DOI: 10.1016/j.cca.2015.09.016     Document Type: Article

References (22)

1. Alpert J.S., Thygesen K., Antman E., Bassand J.P. 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. 2000, 36:959-969.
2. Thygesen K., Mair J., Katus H., et al. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur. Heart J. 2010, 31:2197-2204.
3. Thygesen K., Mair J., Giannitsis E., et al. How to use high-sensitivity cardiac troponins in acute cardiac care. Eur. Heart J. 2012, 33:2252-2257.
4. Thygesen K., Alpert J.S., Jaffe A.S., et al. Third universal definition of myocardial infarction. J. Am. Coll. Cardiol. 2012, 60:1581-1598.
5. Newby L.K., Jesse R.L., Babb J.D., et al. ACCF 2012 expert consensus document on practical clinical considerations in the interpretation of troponin elevations: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. J. Am. Coll. Cardiol. 2012, 60:2427-2463.
6. Casagranda I., Cavazza M., Clerico A., et al. Proposal for the use in emergency departments of cardiac troponins measured with the latest generation methods in patients with suspected acute coronary syndrome without persistent ST-segment elevation. Clin. Chem. Lab. Med. 2013, 51:1727-1737.
7. Panteghini M., Pagani F., Yeo K.T., et al. Evaluation of imprecision for cardiac troponin assays at low-range concentrations. Clin. Chem. 2004, 50:327-332.
8. Apple F.S., Jesse R.L., Newby L.K., et al. 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, 53:547-551.
9. Apple F.S. A new season for cardiac troponin assays: it's time to keep a scorecard. Clin. Chem. 2009, 55:1303-1306.
10. Clerico A., Giannoni A., Prontera T., Giovannini S. High-sensitivity troponin: a new toll for pathophysiological investigation and clinical practice. Adv. Clin. Chem. 2009, 49:1-30.
11. Apple F.S., Collinson P.O. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin. Chem. 2012, 58:54-61.
12. CLSI EP17-A protocol. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guidelines 2004, vol. 24, No. 34. (Wayne, Pennsylvania).
13. CLSI EP5-A2 protocol. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition 2004, vol. 24, No. 25. (Wayne, Pennsylvania).
14. Prontera C., Fortunato A., Storti S., et al. Evaluation of analytical performance of the Siemens ADVIA TnI ultra immunoassay. Clin. Chem. 2007, 53:1722-1723.
15. Greene D.N., Holmes D.T., Liang J., et al. Challenges in harmonizing integrated healthcare network laboratories: multicenter evaluation of the AccuTnI+3 troponin assay. Clin. Biochem. 2015, 48:268-274.
16. Greene D.N., Leong T.K., Collinson P.O., et al. Age, sex, and racial influences on the Beckman Coulter AccuTnI+3 99th percentile. Clin. Chim. Acta 2015, 444:149-153.
17. Franzini M., Prontera C., Masotti S., et al. Evaluation of analytical performance of a novel immunoenzymometric assay for cTnI. Clin. Chim. Acta 2013, 416:48-49.
18. Krintus M., Kozinski M., Boudry P., et al. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay. Clin. Chem. Lab. Med. 2014, 52:1657-1665.
19. Prontera C., Zaninotto M., Giovannini S., et al. Proficiency testing project for brain natriuretic peptide (BNP) and the N-terminal part of the propeptide of BNP (NT-proBNP) immunoassays: the CardioOrmoCheck study. Clin. Chem. Lab. Med. 2009, 47:762-768.
20. Storrow A.B., Christenson R.H., Nowak R.M., et al. Diagnostic performance of cardiac Troponin I for early rule-in and rule-out of acute myocardial infarction: results of a prospective multicenter trial. Clin. Biochem. 2015, 48:254-259.
21. Storrow A.B., Nowak R.M., Diercks D.B., et al. Absolute and relative changes (delta) in troponin I for early diagnosis of myocardial infarction: results of a prospective multicenter trial. Clin. Biochem. 2015, 48:260-267.
22. Bates K.J., Hall E.M., Fahie-Wilson M.N., et al. Circulating immunoreactive cardiac troponin forms determined by gel filtration chromatography after acute myocardial infarction. Clin. Chem. 2010, 56:952-958.