Abstract
Background: International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL).
Methods: Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ) linearity of dilution, interferences, sample type, method comparisons, and 99th percentile URLs were evaluated in this study.
Results: Total imprecision of 3.3%–8.9%, 2.0%–3.5% and 1.5%–5.2% was determined for the low, medium and high controls, respectively. The lowest cTnI concentration corresponding to a total CV of 10% was 5.6 ng/L. Common interferences, sample dilution and carryover did not affect the hs-cTnI results. Slight, but statistically significant, differences with sample type were found. Concordance between the investigated hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively. The 99th percentile values were gender dependent.
Conclusions: The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool.
Acknowledgments
Abbott Laboratories provided the protocol, the reagents, calibrators, controls and minor support for this study. We thank the laboratory scientists and technicians who participated in the study, particularly Slawomir Manysiak (Laboratory Medicine, Bydgoszcz), Magali Grastilleur (Biochimie, Paris), Rosemarie Lott (Laboratory Medicine, Mainz) and Rønnaug Grude (Clinical Biochemistry, Stavanger).
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. The minor support by Abbott Diagnostics played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Research funding: None declared.
Employment or leadership: L. Lennartz and J. Shih are employees of Abbott Laboratories.
Honorarium: G. Lefevre received a speaker honoraria from Abbott.
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The online version of this article (DOI: 10.1515/cclm-2014-0107) offers supplementary material, available to authorized users.
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