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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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Volume 56, Issue 1


Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay

Giuseppe LippiORCID iD: http://orcid.org/0000-0001-9523-9054 / Anna Ferrari / Giorgio Gandini / Matteo Gelati / Claudia Lo Cascio / Gian Luca Salvagno
Published Online: 2017-07-12 | DOI: https://doi.org/10.1515/cclm-2017-0350



This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI).


The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36±12 years; 47% women) and comparison with two other commercial cTnI immunoassays.


The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%–2.9%, 4.6%–5.4%, and 5.4%–6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r=1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r=0.97; mean bias, −9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r=0.95; mean bias, −55%).


The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.

Keywords: immunoassay; method evaluation; myocardial infarction; troponin


  • 1.

    Cervellin G, Mattiuzzi C, Bovo C, Lippi G. Diagnostic algorithms for acute coronary syndrome-is one better than another? Ann Transl Med 2016;4:193.Web of ScienceCrossrefPubMedGoogle Scholar

  • 2.

    Ferraro S, Panteghini M. Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm. Clin Chem Lab Med 2015;53:653–64.PubMedWeb of ScienceGoogle Scholar

  • 3.

    Lackner KJ. Do we really need high-sensitive troponin immunoassays in the emergency department? Definitely, yes! Clin Chem Lab Med 2014;52:201–4.PubMedWeb of ScienceGoogle Scholar

  • 4.

    Lippi G, Cervellin G. Cardiospecific troponin immunoassays: How low is it worth to go? Eur J Intern Med 2016;30:e7–8.CrossrefWeb of ScienceGoogle Scholar

  • 5.

    Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, et al. High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet 2015;386:2481–8.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 6.

    Ferraro S, Dolci A, Panteghini M. Fast track protocols using highly sensitive troponin assays for ruling out and ruling in non-ST elevation acute coronary syndrome. Clin Chem Lab Med 2017;55:1683–9.Web of SciencePubMedGoogle Scholar

  • 7.

    Lippi G. The mystifying nomenclature of cardiac troponin immunoassays. Scand J Clin Lab Invest 2014;74:273–7.CrossrefWeb of SciencePubMedGoogle Scholar

  • 8.

    Giannitsis E, Kurz K, Hallermayer K, Jarausch J, Jaffe AS, Katus HA. Analytical validation of a high-sensitivity cardiac troponin T assay. Clin Chem 2010;56:254–61.Web of ScienceCrossrefPubMedGoogle Scholar

  • 9.

    Lackner KJ. High-sensitivity assays for cardiac troponins. Clin Chem Lab Med 2015;53:631–3.PubMedWeb of ScienceGoogle Scholar

  • 10.

    Kavsak PA, MacRae AR, Yerna MJ, Jaffe AS. Analytic and clinical utility of a next-generation, highly sensitive cardiac troponin I assay for early detection of myocardial injury. Clin Chem 2009;55:573–7.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 11.

    Armbruster DA, Pry T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev 2008;29 Suppl 1:S49–52.PubMedGoogle Scholar

  • 12.

    Krouwer JS, Rabinowitz R. How to improve estimates of imprecision. Clin Chem 1984;30:290–2.PubMedGoogle Scholar

  • 13.

    Clinical and Laboratory Standards Institute. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd ed. Document EP28-A3C. CLSI, Wayne, PA, USA, 2010.Google Scholar

  • 14.

    Lippi G, Dipalo M, Avanzini P, Formentini A, Aloe R. Analytical assessment of the Beckman Coulter Unicel DxI AccuTnI+3 immunoassay. Diagnosis 2014;1:195–7.Google Scholar

  • 15.

    Arrebola MM, Lillo JA, Diez De Los Ríos MJ, Rodríguez M, Dayaldasani A, Yahyaoui R, et al. Analytical performance of a sensitive assay for cardiac troponin I with loci technology. Clin Biochem 2010;43:998–1002.Web of ScienceCrossrefPubMedGoogle Scholar

  • 16.

    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.PubMedWeb of ScienceGoogle Scholar

  • 17.

    Zeller T, Ojeda F, Brunner FJ, Peitsmeyer P, Münzel T, Binder H, et al. High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study. Clin Chem Lab Med 2015;53:699–706.Web of SciencePubMedGoogle Scholar

  • 18.

    Krintus M, Kozinski M, Boudry P, Lackner K, Lefèvre G, Lennartz L, et al. Defining normality in a European multinational cohort: Critical factors influencing the 99th percentile upper reference limit for high sensitivity cardiac troponin I. Int J Cardiol 2015;187:256–63.CrossrefWeb of ScienceGoogle Scholar

  • 19.

    Schofer N, Brunner FJ, Schlüter M, Ojeda F, Zeller T, Baldus S, et al. Gender-specific diagnostic performance of a new high-sensitivity cardiac troponin I assay for detection of acute myocardial infarction. Eur Heart J Acute Cardiovasc Care 2017;6:60–8.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 20.

    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.Web of SciencePubMedCrossrefGoogle Scholar

  • 21.

    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 Chim Acta 2016;456:42–8.Google Scholar

  • 22.

    Lippi G, Cervellin G. Degradation of troponin I in serum or plasma: mechanisms, and analytical and clinical implications. Semin Thromb Hemost 2012;38:222–9.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 23.

    Panteghini M, Pagani F, Yeo KT, Apple FS, Christenson RH, Dati F, et al. Evaluation of imprecision for cardiac troponin assays at low-range concentrations. Clin Chem 2004;50:327–32.CrossrefPubMedGoogle Scholar

  • 24.

    Krintus M, Kozinski M, Boudry P, Capell NE, Köller U, Lackner K, et al. European multicenter analytical evaluation of the Abbott ARCHITECT STAT highly sensitive troponin I immunoassay. Clin. Chem Lab Med 2014;52:1657–65.Google Scholar

  • 25.

    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.Web of SciencePubMedGoogle Scholar

  • 26.

    Lippi G. Biomarkers: Novel troponin immunoassay for early ACS rule-out. Nat Rev Cardiol 2016;13:9–10.PubMedGoogle Scholar

About the article

Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry, University Hospital of Verona, P.le LA Scuro 10, 37134 Verona, Italy

Received: 2017-04-22

Accepted: 2017-06-01

Published Online: 2017-07-12

Published in Print: 2017-11-27

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

Research funding: None.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The reagents used in this study were provided by Beckman Coulter, but the company 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.

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 56, Issue 1, Pages 157–161, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0350.

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