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Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project.

Tate, J R*; Bunk, D M*; Christenson, R H*; Barth, J H*; Katrukha, A*; Noble, J E; Schimmel, H*; Wang, L L*; Panteghini, M* (2015) Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project. Clin. Chem. Lab. Med., 53 (5). pp. 677-690.

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Abstract

Background: As a part of an IFCC project to prepare a commutable reference material for cardiac troponin I (cTnI), a pilot study evaluated current cTnI assays for measurement equivalence and their standardization capability. Methods: cTnI-positive samples collected from 90 patients with suspected acute myocardial infarction were assessed for method comparison by 16 cTnI commercial assays according to predefined testing protocols. Seven serum pools prepared from these samples were also assessed. Results: Each assay was assessed against median cTnI concentrations measured by 16 cTnI assays using Passing-Bablok regression analysis of 79 patient samples with values above each assay's declared detection limit. We observed a 10-fold difference in cTnI concentrations for lowest to highest measurement results. After mathematical recalibration of assays, the betweenassay variation for patient samples reduced on average from 40 % to 22 % at low cTnI concentration, 37 % to 20 % at medium concentration, and 29 % to 14 % at high concentration. The average reduction for pools was larger at 16 %, 13 % and 7 % for low, medium and high cTnI concentrations, respectively. Overall, assays demonstrated negligible bias after recalibration (y-intercept: -1.4 to 0.3 ng/L); however, a few samples showed substantial positive and/or negative differences for individual cTnI assays. Conclusions: All of the 16 commercial cTnI assays evaluated in the study demonstrated a significantly higher degree of measurement equivalence after mathematical recalibration, indicating that measurement harmonization or standardization would be affective at reducing inter-assay bias. Pooled sera behaved similarly to individual samples in most assays.

Item Type: Article
Keywords: biomarker
Subjects: Biotechnology
Biotechnology > Bio-Diagnostics
Identification number/DOI: 10.1515/cclm-2014-1197
Last Modified: 02 Feb 2018 13:13
URI: http://eprintspublications.npl.co.uk/id/eprint/6657

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