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Analytical characterization of the Siemens Dimension EXL high-sensitivity cardiac troponin I assay

Peter A Kavsak1, Jackie MacCuish2, Jill Boreyko2

  • 1Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada.

Clinical Biochemistry
|May 8, 2019
PubMed

Insights

The Siemens Dimension EXL high-sensitivity troponin I (hs-cTnI) assay demonstrates analytical performance meeting high-sensitivity criteria. Assay-specific cutoffs are crucial for optimizing clinical utility and patient outcomes.

Area of Science:

  • Clinical Chemistry
  • Cardiovascular Diagnostics
  • Biomarker Assay Development

Background:

  • Siemens Healthcare Diagnostics offers multiple cardiac troponin I (cTnI) assays with varying methodologies.
  • This study evaluates the analytical performance of the Dimension EXL hs-cTnI assay using the LOCI method.

Purpose of the Study:

  • To assess the analytical performance of the Siemens Dimension EXL hs-cTnI assay.
  • To compare the Dimension EXL hs-cTnI assay with other high-sensitivity troponin I assays (ADVIA Centaur and Abbott ARCHITECT) across different biological matrices.

Main Methods:

  • Determined analytical sensitivity and precision of the Dimension EXL hs-cTnI assay below the 99th percentile.
  • Conducted method comparisons between Dimension EXL contemporary cTnI and hs-cTnI assays.
  • Performed cross-matrix comparisons (serum, lithium heparin, EDTA plasma) for the EXL hs-cTnI assay.
  • Compared the EXL hs-cTnI assay against ADVIA Centaur and Abbott ARCHITECT hs-cTnI assays using non-parametric analyses.

Main Results:

  • The Dimension EXL hs-cTnI assay exhibited a limit of detection of 1.7 ng/L and imprecision below 5.8%.
  • Comparisons revealed proportional differences in troponin I concentrations between assays and matrices, particularly at higher concentrations.
  • The EXL hs-cTnI assay showed higher concentrations compared to Abbott ARCHITECT hs-cTnI in EDTA plasma and across all matrices below 100 ng/L.

Conclusions:

  • The Siemens Dimension EXL hs-cTnI assay meets the analytical requirements for high-sensitivity troponin detection.
  • Establishing assay-specific cutoffs is essential for maximizing the clinical performance and diagnostic accuracy of the Dimension EXL hs-cTnI assay.
Abstract

Keywords:
AnalyticalHigh-sensitivity cardiac troponin IMatrixMethod comparison

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