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Licensed Unlicensed Requires Authentication Published by De Gruyter September 23, 2017

Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I

  • Silvia Masotti , Concetta Prontera , Veronica Musetti , Simona Storti , Rudina Ndreu , Gian Carlo Zucchelli , Claudio Passino and Aldo Clerico EMAIL logo

Abstract

Background:

The study aim was to evaluate and compare the analytical performance of the new chemiluminescent immunoassay for cardiac troponin I (cTnI), called Access hs-TnI using DxI platform, with those of Access AccuTnI+3 method, and high-sensitivity (hs) cTnI method for ARCHITECT platform.

Methods:

The limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CV were evaluated according to international standardized protocols. For the evaluation of analytical performance and comparison of cTnI results, both heparinized plasma samples, collected from healthy subjects and patients with cardiac diseases, and quality control samples distributed in external quality assessment programs were used.

Results:

LoB, LoD and LoQ at 20% and 10% CV values of the Access hs-cTnI method were 0.6, 1.3, 2.1 and 5.3 ng/L, respectively. Access hs-cTnI method showed analytical performance significantly better than that of Access AccuTnI+3 method and similar results to those of hs ARCHITECT cTnI method. Moreover, the cTnI concentrations measured with Access hs-cTnI method showed close linear regressions with both Access AccuTnI+3 and ARCHITECT hs-cTnI methods, although there were systematic differences between these methods. There was no difference between cTnI values measured by Access hs-cTnI in heparinized plasma and serum samples, whereas there was a significant difference between cTnI values, respectively measured in EDTA and heparin plasma samples.

Conclusions:

Access hs-cTnI has analytical sensitivity parameters significantly improved compared to Access AccuTnI+3 method and is similar to those of the high-sensitivity method using ARCHITECT platform.

Acknowledgments

All the immunoassay kits used in this study were kindly supported by the manufacturers, namely, Beckman Coulter S.r.l. Italy (Cassina de’ Pecchi, Milan, Italy) and Abbott Diagnostics Italia (Rome, Italy).

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Alpert JS, Thygesen K, Antman E, Bassand JP. 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;36:959–69.10.1016/S0735-1097(00)00804-4Search in Google Scholar

2. Clerico A, Fortunato A, Ripoli A, Prontera C, Zucchelli GC, Emdin M. Distribution of plasma cardiac troponin I values in healthy subjects: pathophysiological considerations. Clin Chem Lab Med 2008;46:804–8.10.1515/CCLM.2008.162Search in Google Scholar PubMed

3. Giannoni A, Giovannini S, Clerico A. Measurement of circulating concentrations of cardiac troponin I and T in healthy subjects: a tool for monitoring myocardial tissue renewal? Clin Chem Lab Med 2009;47:1167–77.10.1515/CCLM.2009.320Search in Google Scholar PubMed

4. Clerico A, Zaninotto M, Ripoli M, Masotti S, Prontera C, Passino C, et al. The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology, and clinical implications. Clin Chem Lab Med 2017; accepted for publication, date February 28, 2017.10.1515/cclm-2016-0933Search in Google Scholar PubMed

5. Marjot J, Kaier TE, Martin ED, Reji SS, Copeland O, Iqbal M, et al. Quantifying the release of biomarkers of myocardial necrosis from cardiac myocytes and intact myocardium. Clin Chem 2017;63:990–6.10.1373/clinchem.2016.264648Search in Google Scholar PubMed PubMed Central

6. Prontera C, Fortunato A, Storti S, Mercuri A, Longombardo G, Zucchelli GC, et al. Evaluation of analytical performance of the Siemens ADVIA TnI ultra immunoassay. Clin Chem 2007;53: 1722–3.10.1373/clinchem.2007.089995Search in Google Scholar PubMed

7. 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;412:748–54.10.1016/j.cca.2010.12.034Search in Google Scholar PubMed

8. Venge P, James S, Jansson L, Lindahl B. Clinical performance of two highly sensitive cardiac troponin I assays. Clin Chem 2009;55:109–16.10.1373/clinchem.2008.106500Search in Google Scholar PubMed

9. Krintus M, Kozinsk M, Boudry P, Capell NE, Köller U, Lackner K, et al. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay. Clin Chem Lab Med 2016;52:1657–65.10.1515/cclm-2014-0107Search in Google Scholar PubMed

10. Caselli C, Cangemi G, Masotti S, Ragusa R, Gennai I, Del Ry S, et al. Plasma cardiac troponin I concentrations in healthy neonates, children and adolescents measured with a high sensitive immunoassay method: high sensitive troponin I in pediatric age. Clin Chim Acta 2016;458:68–71.10.1016/j.cca.2016.04.029Search in Google Scholar PubMed

11. Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Clin Chem 2007;53:552–74.10.1373/clinchem.2006.084194Search in Google Scholar PubMed

12. Apple FS, Jesse RL, Newby LK, Wu AH, Christenson RH, Cannon CP, 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;53:547–51.10.1373/clinchem.2006.084715Search in Google Scholar PubMed

13. 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;58:1574–81.10.1373/clinchem.2012.192716Search in Google Scholar PubMed

14. Thygesen K, Alpert JS, White HD, Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol 2007;50:2173–95.10.1016/j.jacc.2007.09.011Search in Google Scholar PubMed

15. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third Universal Definition of myocardial infarction. Eur Heart J 2012;33:2551–67.10.1093/eurheartj/ehs184Search in Google Scholar PubMed

16. Apple FS, Collinson PO; IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem 2012;58:54–61.10.1373/clinchem.2011.165795Search in Google Scholar PubMed

17. 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;33:2252–7.10.1093/eurheartj/ehs154Search in Google Scholar PubMed

18. Casagranda I, Cavazza M, Clerico A, Galvani M, Ottani F, Zaninotto M, 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;51:1727–37.10.1515/cclm-2013-0423Search in Google Scholar PubMed

19. Sandoval Y, Apple FS. The global need to define normality: the 99th percentile value of cardiac troponin. Clin Chem 2014;60:455–62.10.1373/clinchem.2013.211706Search in Google Scholar PubMed

20. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016;37:267–315.10.1093/eurheartj/ehv320Search in Google Scholar PubMed

21. Apple FS, Saenger AK. The state of cardiac troponin assay: looking bright and moving in the tight direction. Clin Chem 2013;59:1014–6.10.1373/clinchem.2013.203307Search in Google Scholar PubMed

22. CLSI EP17-A protocol. Protocols for determination of limits of detection and limits of quantitation; approved guidelines. Wayne, Pennsylvania, 2004;24.Search in Google Scholar

23. CLSI EP5-A2 protocol. Evaluation of precision performance of quantitative measurement methods; Approved guideline – Second edition, Wayne, Pennsylvania, 2004;24.Search in Google Scholar

24. Storti S, Masotti S, Prontera C, Franzini M, Buzzi P, Casagranda I, et al. 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. Clin Chim Acta 2015;451:129–34.10.1016/j.cca.2015.09.016Search in Google Scholar PubMed

25. Franzini M, Prontera C, Masotti S, Zucchelli GC, Storti S, Passino C, et al. Evaluation of analytical performance of a novel immunoenzymometric assay for cTnI. Clin Chim Acta 2013;416:48–9.10.1016/j.cca.2012.11.018Search in Google Scholar PubMed

26. Clerico A, Ripoli A, Masotti S, Prontera C, Storti S, Fortunato A, et al. Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Società Italiana di Biochimica Clinica (SIBioC). Clin Chem Acta 2016;456:42–8.10.1016/j.cca.2016.02.017Search in Google Scholar PubMed

27. Franzini M, Lorenzoni V, Masotti S, Prontera C, Chiappino D, Latta DD, et al. The calculation of the cardiac troponin T 99th percentile of the reference population is affected by age, gender, and population selection: a multicenter study in Italy. Clin Chim Acta 2015;438:376–81.10.1016/j.cca.2014.09.010Search in Google Scholar PubMed

28. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239.10.1161/CIR.0b013e31829e8776Search in Google Scholar PubMed

29. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016;18:891–975.10.1002/ejhf.592Search in Google Scholar PubMed

30. Apple FS, Collinson PO. Analytical characteristics of high-sensitivty cardica troponin assay. Clin Chem 2012;58:54–61.10.1373/clinchem.2011.165795Search in Google Scholar PubMed


Supplemental Material:

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2017-0387).


Received: 2017-5-6
Accepted: 2017-8-11
Published Online: 2017-9-23
Published in Print: 2018-2-23

©2018 Walter de Gruyter GmbH, Berlin/Boston

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