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Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

Peter A Kavsak1,2, Tara Edge3, Chantele Roy3

  • 1McMaster University, Hamilton, ON, Canada.

Clinical Chemistry and Laboratory Medicine
|October 20, 2020
PubMed

Insights

The Ortho VITROS high-sensitivity cardiac troponin I assay shows excellent clinical performance for myocardial infarction detection. However, it yields lower results compared to other assays and has differences between serum and plasma. Standardization is needed.

Area of Science:

  • Clinical Chemistry
  • Cardiovascular Diagnostics
  • Biomarker Assay Evaluation

Background:

  • High-sensitivity cardiac troponin I (hs-cTnI) assays are crucial for diagnosing myocardial infarction (MI).
  • Standardization across different manufacturers remains a challenge, impacting clinical interpretation.

Purpose of the Study:

  • To analytically evaluate the Ortho Clinical Diagnostics VITROS hs-cTnI assay.
  • To compare its performance in serum and lithium heparin (Li-Hep) plasma against other hs-cTnI assays.

Main Methods:

  • Assessed limit of detection (LoD), imprecision, interference, and stability for the VITROS hs-cTnI assay in serum and Li-Hep plasma.
  • Performed Passing-Bablok regression analyses and Receiver-operating characteristic (ROC) curve analyses in an emergency department (ED) population for MI detection.

Main Results:

  • VITROS hs-cTnI assay demonstrated an LoD of 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep).
  • Serum showed superior analyte stability compared to Li-Hep plasma, which was also affected by hemolysis.
  • The assay yielded proportionally lower concentrations in Li-Hep plasma (slope=0.85) and compared to other hs-cTnI assays in serum.
  • Achieved an area under the curve (AUC) of 0.974 for MI detection in the ED study, comparable to other hs-cTn assays.

Conclusions:

  • The VITROS hs-cTnI assay exhibits excellent clinical performance for MI detection, comparable to other hs-cTn assays.
  • Significant differences exist between serum and Li-Hep plasma results, highlighting the need for matrix-specific interpretation.
  • Lack of standardization among hs-cTnI assays necessitates further investigation and harmonization efforts.
Abstract

Keywords:
analytical variationhigh-sensitivity cardiac troponininterferencelithium heparin plasmamatrixserumstability

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