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Licensed Unlicensed Requires Authentication Published by De Gruyter October 21, 2020

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

  • Peter A. Kavsak EMAIL logo , Tara Edge , Chantele Roy , Paul Malinowski , Karen Bamford , Lorna Clark , Shana Lamers , Stephen Hill and Andrew Worster

Abstract

Objectives

To analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.

Methods

The limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).

Results

The VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.

Conclusions

Lack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.


Corresponding author: Dr. Peter A. Kavsak, McMaster University, Juravinski Hospital and Cancer Centre, 711 Concession Street Hamilton, Hamilton, ON L8V 1C3, Canada; and Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada, Phone: +1 905 521 2100, E-mail:

Award Identifier / Grant number: 100015302

Acknowledgments

Ortho Clinical Diagnostics for the supplies and funding to perform this study.

  1. Research funding: This analytical study was funded by Ortho Clinical Diagnostics.

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

  3. Competing interests: Dr. Kavsak has received grants/reagents/consultant/advisor/honoraria from Abbott Laboratories, Beckman Coulter, Ortho Clinical Diagnostics, Randox Laboratories, Roche Diagnostics and Siemens Healthcare Diagnostics. McMaster University has filed patents with Dr. Kavsak listed as an inventor in the acute cardiovascular biomarker field.

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

  5. Ethical approval: This study was approved by the Hamilton Integrated Research Ethics Board (Project Number 8013-T).

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Received: 2020-07-20
Accepted: 2020-10-05
Published Online: 2020-10-21
Published in Print: 2021-03-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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