European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin i immunoassay

Clinical Chemistry and Laboratory Medicine

Volumn 52, Issue 11, 2014, Pages 1657-1665

  Krintus, Magdalena ^a   Kozinski, Marek ^a   Boudry, Pascal ^b   Capell, Nuria Estañ ^c   Köller, Ursula ^d   Lackner, Karl ^e   Lefèvre, Guillaume ^f   Lennartz, Lieselotte ^g   Lotz, Johannes ^e   Herranz, Antonio Mora ^c   Nybo, Mads ^h   Plebani, Mario ⁱ   Sandberg, Maria B ^h   Schratzberger, Wolfgang ^d   Shih, Jessie ^j   Skadberg, Øyvind ^k   Chargui, Ahmed Taoufik ^f   Zaninotto, Martina ⁱ   Sypniewska, Grazyna ^a  

^a NICOLAUS COPERNICUS UNIVERSITY   (Poland)

^b CHR Mons Hainaut ^*  (Belgium)

^c HOSPITAL UNIVERSITARIO DR PESET   (Spain)

^d Wiener Krankenanstaltenverbund   (Austria)

^e UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^f HÔPITAL TENON   (France)

^g ABBOTT GMBH AND CO KG   (Germany)

^h ODENSE UNIVERSITY HOSPITAL   (Denmark)

ⁱ UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^j ABBOTT LABORATORIES   (United States)

^k STAVANGER UNIVERSITY HOSPITAL   (Norway)

more..

Author keywords

99th percentile upper reference limit; analytical evaluation; analytical performance; high sensitive troponin

Indexed keywords

TROPONIN I; DIAGNOSTIC KIT;

ADULT; AGED; ARCHITECT STAT HS-TNI ASSAY; ARCHITECT STAT TNI ASSAY; ARTICLE; CONTROLLED STUDY; FEMALE; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; INTERMETHOD COMPARISON; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MALE; MULTICENTER STUDY; ADOLESCENT; BLOOD; BLOOD CLOTTING TEST; CLINICAL TRIAL; COMPARATIVE STUDY; DEVICES; DIAGNOSTIC KIT; EUROPE; EVALUATION STUDY; LABORATORY; MIDDLE AGED; SENSITIVITY AND SPECIFICITY; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD COAGULATION TESTS; EUROPE; FEMALE; HUMANS; IMMUNOASSAY; LABORATORIES; MALE; MIDDLE AGED; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; TROPONIN I; YOUNG ADULT;

EID: 84908093975     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2014-0107     Document Type: Article

References (36)

1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol 2012;60:1581-98
2. Apple FS, Collinson PO. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem 2012;58:54-61
3. Koerbin G, Abhayaratna WP, Potter JM, Apple FS, Jaffe AS, Ravalico TH, et al. Effect of population selection on 99th percentile values for a high sensitivity cardiac troponin I and T assays. Clin Biochem 2013;46:1636-43
4. 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
5. Apple FS, Saenger AK. The state of cardiac troponin assays: looking bright and moving in the right direction. Clin Chem 2013;59:1014-6
6. Thygesen K, Mair J, Giannitsis E, Mueller C, Lindahl B, Blankenberg S, et al. How to use high-sensitivity cardiac troponins in acute cardiac care. Eur Heart J 2012;33:2252-7
7. Tate JR, Bunk DM, Christenson RH, Katrukha A, Noble JE, Porter RA, et al. Standardisation of cardiac troponin I measurement: past and present. Pathology 2010;42:402-8
8. International Federation of Clinical Chemistry and Laboratory Medicine. Troponin assay analytical characteristics 2013. Available from: http://www.ifcc.org/media/245272/IFCC%20 Troponin%20I%20and%20T%20%28ug-L%20units%29%20- update%20December%202013.pdf. Accessed 1 May, 2014
9. Clinical Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods; approved guidelines, EP5-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2004
10. Clinical Laboratory Standards Institute. Evaluation of detection capability for clinical laboratory measurement procedures; approved guidelines, 2nd ed, EP17-A2. Wayne, PA: Clinical and Laboratory Standard Institute, 2012
11. Clinical Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guidelines, EP6-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2003
12. Clinical Laboratory Standards Institute. Interference testing in clinical chemistry; approved guideline, 2nd ed. EP7-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2005
13. Clinical Laboratory Standards Institute. Defining, establishing and verifying reference intervals in the clinical laboratory; approved guideline, 3rd ed. EP28-A3c. Wayne, PA: Clinical and Laboratory Standards Institute, 2010
14. Reed AH, Henry RJ, Mason WB. Influence of statistical method used on the resulting estimate of normal range. Clin Chem 1971;17:275-84
15. Apple FS. A new season for cardiac troponin assays: it's time to keep a scorecard. Clin Chem 2009;55:1303-6
16. Marini MG, Cardillo MT, Caroli A, Sonnino C, Biasucci LM. Increasing specificity of high-sensitivity troponin: new approaches and perspectives in the diagnosis of acute coronary syndromes. J Cardiol 2013;62:205-9
17. Abbott ARCHITECT STAT high sensitive troponin-I. Package insert. G1-0139/R02. 2013
18. Apple FS, Ler R, Murakami MM. Determination of 19 cardiac troponin I and T assay 99th percentile values from a common presumably healthy population. Clin Chem 2012;58:1574-81
19. James S, Flodin M, Johnston N, Lindahl B, Venge P. The antibody configurations of cardiac troponin I assays may determine their clinical performance. Clin Chem 2006;52:832-7
20. Panteghini M, Gerhardt W, Apple FS, Dati F, Ravkilde J, Wu AH. Quality specifications for cardiac troponin assays. Clin Chem Lab Med 2001;39:175-9
21. Ji JZ, Meng QH. Evaluation of the interference of hemoglobin, bilirubin, and lipids on Roche Cobas 6000 assays. Clin Chim Acta 2011;412:1550-3
22. Sztefko K. Troponin measurement by immunoassay-problem of low assay sensitivity and interference from heterophilic antibodies. In: Sztefko K, editor. Immunodiagnostics and patient safety. Berlin: De Gruyter, 2013:129-36
23. Plebani P, Lippi G. Hemolysis index: quality indicator or criterion for sample rejection? Clin Chem Lab Med 2009;47:899-902
24. Koerbin G, Tate J, Potter JM, Cavanaugh J, Glasgow N, Hickman PE. Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population. Clin Chem Lab Med 2012;50:871-8
25. Bais R. The effect of sample hemolysis on cardiac troponin I and T assays. Clin Chem 2010;56:1357-9
26. Tate JR, Panteghini M. Measurement of cardiac troponins revisited. Biochim Clin 2013;32:535-46
27. Schiettecatte J, Anckaert, Smitz J. Interferences in immunoassays. In: Norman HL, Christopoulos TK, editors. Advances in immunoaasay technologies. Rijeka: InTech, 2013:45-62
28. Pagani F, Stefini F, Chapelle JP, Lefevre G, Graine H, Luthe H, et al. Multicenter evaluation of analytical performance of the Liaison troponin I assay. Clin Biochem 2004;37:750-7
29. Jardine RM, Dalby AJ, Klug EQ, Vermaak WH, White HD, Badenhorst JC, et al. Consensus statement on the use of high sensitivity cardiac troponins. SA Heart J 2013;9:1-8
30. Lippi G, Avanzini P, Musa R, Aloe R, Cervellin G. Carryover does not affect results of Beckman Coulter highly-sensitive-AccuTnI assay on Access 2. Clin Chem Lab Med 2013;51:e141-3
31. Saenger AK, 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;412:748-54
32. 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
33. de Lemos JA, Morrow DA, deFilippi CR. Highly sensitive troponin assays and the cardiology community: a love/hate relationship? Clin Chem 2011;57:826-9
34. Korley FK, Jaffe AS. Preparing the United States for high-sensitivity cardiac troponin assays. J Am Coll Cardiol 2013;61:1753-8
35. Pretorius CJ, Dimeski G, O'Rourke PK, Marquart L, Tyack SA, Wilgen U, et al. Outliers as a cause of false cardiac troponin results: investigating the robustness of 4 contemporary assays. Clin Chem 2011;57:710-8
36. Sawyer N, Blennerhassett J, Lambert R, Sheehan P, Vasikaran SD. Outliers affecting cardiac troponin I measurement: comparison of a new high sensitivity assay with a contemporary assay on the Abbott ARCHITECT analyser. Ann Clin Biochem 2014;51. Epub ahead of print 23 Sep 2013. DOI: 10.1177/000456321349937.