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

  • Giuseppe Lippi ORCID logo EMAIL logo , Anna Ferrari , Giorgio Gandini , Matteo Gelati , Claudia Lo Cascio and Gian Luca Salvagno
Published/Copyright: July 12, 2017
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 1

Abstract

Background:

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).

Methods:

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.

Results:

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%).

Conclusions:

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

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.

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Received: 2017-4-22
Accepted: 2017-6-1
Published Online: 2017-7-12
Published in Print: 2017-11-27

©2018 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2017-0350
Keywords for this article
immunoassay; method evaluation; myocardial infarction; troponin

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Method comparison – a practical approach based on error identification
  4. Review
  5. Neutrophil gelatinase-associated lipocalin as a risk marker in cardiovascular disease
  6. Mini Reviews
  7. α-Defensin point-of-care test for diagnosis of prosthetic joint infections: neglected role of laboratory and clinical pathologists
  8. The diagnostic accuracy of biomarkers for diagnosis of primary biliary cholangitis (PBC) in anti-mitochondrial antibody (AMA)-negative PBC patients: a review of literature
  9. Opinion Paper
  10. New issues on measurement of B-type natriuretic peptides
  11. Genetics and Molecular Diagnostics
  12. The SEeMORE strategy: single-tube electrophoresis analysis-based genotyping to detect monogenic diseases rapidly and effectively from conception until birth
  13. General Clinical Chemistry and Laboratory Medicine
  14. Determination of serum calcium levels by 42Ca isotope dilution inductively coupled plasma mass spectrometry
  15. The effects of dry ice exposure on plasma pH and coagulation analyses
  16. Placental protein-13 (PP13) in combination with PAPP-A and free leptin index (fLI) in first trimester maternal serum screening for severe and early preeclampsia
  17. Circulating CD89-IgA complex does not predict deterioration of kidney function in Korean patients with IgA nephropathy
  18. Performance analysis of automated evaluation of Crithidia luciliae-based indirect immunofluorescence tests in a routine setting – strengths and weaknesses
  19. Performance of automated digital cell imaging analyzer Sysmex DI-60
  20. Reference Values and Biological Variations
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  22. Reference intervals and longitudinal changes in copeptin and MR-proADM concentrations during pregnancy
  23. Definition of the upper reference limit of glycated albumin in blood donors from Italy
  24. Reference values of fecal calgranulin C (S100A12) in school aged children and adolescents
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  28. Cardiovascular Diseases
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  31. Infectious Diseases
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  33. Effects of procalcitonin testing on antibiotic use and clinical outcomes in patients with upper respiratory tract infections. An individual patient data meta-analysis
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  35. Letters to the Editor
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