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

Autor:	Kavsak PA; McMaster University, Hamilton, ON, Canada.; Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada., Edge T; Clinical Research Laboratory and Biobank, Hamilton Health Sciences, Hamilton, ON, Canada., Roy C; Clinical Research Laboratory and Biobank, Hamilton Health Sciences, Hamilton, ON, Canada., Malinowski P; Clinical Research Laboratory and Biobank, Hamilton Health Sciences, Hamilton, ON, Canada., Bamford K; Clinical Research Laboratory and Biobank, Hamilton Health Sciences, Hamilton, ON, Canada., Clark L; Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada., Lamers S; Clinical Research Laboratory and Biobank, Hamilton Health Sciences, Hamilton, ON, Canada., Hill S; McMaster University, Hamilton, ON, Canada.; Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada., Worster A; McMaster University, Hamilton, ON, Canada.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2020 Oct 21; Vol. 59 (4), pp. 749-755. Date of Electronic Publication: 2020 Oct 21 (Print Publication: 2021).
DOI:	10.1515/cclm-2020-1115
Abstrakt:	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. (© 2020 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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