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Analytical characteristics and performance of a new hs-cTnI method: a multicenter-study

On behalf of the Study Group on Cardiac Biomarkers of the Italian Societies of Laboratory Medicine SIBioC and ELAS
  • Tommaso Fasano , Antonio Fortunato , Greta Giacomini , Alberto Aimo , Marco Moretti , Valentina Viola , Jacopo Sabbatinelli , Giorgia Farneti , Paolo Maltoni , Rino Biguzzi , Vittorio Sambri , Nadia Di Marco , Andrea Ripoli and Aldo Clerico EMAIL logo
Published/Copyright: January 7, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 4

Abstract

Objectives

The present multicenter study was designed to evaluate the analytical performance and the 99th percentile value of the reference healthy population i.e., 99th percentile upper reference limit of the MAGLUMI® CLIA high-sensitivity cardiac troponin I (hs-cTnI) method.

Methods

Analytical performances and the 99th percentile URL value of the chemi-luminescent-immuno-assay (CLIA) method were evaluated using validated and standardized experimental protocols. Two cohorts including healthy adult individuals were enrolled. The first one included 989 blood donor volunteers (489 women and 500 men) aged 18–70 years (mean age 43 years, interquartile range 31–54 years). The second population included 47 healthy individuals (31 women and 16 men, mean age 78 years, interquartile range 73–81 years) aged≥71 years.

Results

The distributions of hs-cTnI levels in both sexes are highly right-skewed, and men show significantly (p=0.0028) higher biomarker values than women. Moreover, in both sexes the hs-cTnI levels progressively increase after the 55 years. In the multivariate analysis (n=958), hs-cTnI was found to be significantly associated to NT-proBNP (p<0.0001), sex (p<0.0001) and BMI (p=0.0424). The 99th percentile URL values, calculated using the bootstrap method in the total reference heathy population (age≥18 years), were: Females (n=521): 5.93 ng/L (CI 95 % 5.29–8.48), Males (n=516): 9.79 ng/L (CI 95 % 6.37–17.41 ng/L), Total Population (n=1,037): 7.18 ng/L (CI 6.08–12.20 ng/L).

Conclusions

The MAGLUMI CLIA method met all the criteria for an hs-cTnI assay recommended by international guidelines. The hs-cTnI values measured with the CLIA method are higher in men compared to women at the same age, and also progressively increase after the age>55 years.

Keywords: cardiac troponins; acute myocardial infarction; myocardial injury; high-sensitivity immunoassay methods; cardiac biomarkers; cardiovascular risk
Corresponding author: Aldo Clerico, Coordinator of the Italian Study Group of Cardiac Biomarkers, Scuola Superiore Sant’Anna and Fondazione CNR – Regione Toscana G. Monasterio, Pisa, Italy, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Informed consent was obtained from all individuals included in this study.

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

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The raw data can be obtained on request from the corresponding author.

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Received: 2024-08-06
Accepted: 2024-12-02
Published Online: 2025-01-07
Published in Print: 2025-03-26

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0905
Keywords for this article
cardiac troponins; acute myocardial infarction; myocardial injury; high-sensitivity immunoassay methods; cardiac biomarkers; cardiovascular risk

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  27. Cardiovascular Diseases
  28. Analytical characteristics and performance of a new hs-cTnI method: a multicenter-study
  29. Diabetes
  30. Use of labile HbA1c as a screening tool to minimize clinical misinterpration of HbA1c
  31. Letters to the Editor
  32. Current trends and future projections in the clinical laboratory test market: implications for resource management and strategic planning
  33. Particulate matter in water: an overlooked source of preanalytical error producing erroneous chemistry test results
  34. “Activation” of macro-AST by pyridoxal-5-phosphate in the assay for aspartate aminotransferase
  35. The correlation of albumin with total protein concentrations in cerebrospinal fluid across three automated analysers – relevance to the diagnosis of subarachnoid haemorrhage in clinical chemistry practice
  36. Adult reference intervals for serum thyroid‐stimulating hormone using Abbott Alinity i measuring system
  37. Cell population data in venous thrombo-embolism and erysipelas: a potential diagnostic tool?
  38. Diagnostic performances and cut-off verification of blood pTau 217 on the Lumipulse platform for amyloid deposition in Alzheimer’s disease
  39. The first case of Teclistamab interference with serum electrophoresis and immunofixation
  40. Congress Abstracts
  41. Annual meeting of the Royal Belgian Society of Laboratory Medicine (RBSLM): “A Neurological Journey: Brain Teasers for Laboratory Medicine”
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