Abstract
Objectives
To validate the analytical performance and diagnostic accuracy for non-ST-segment elevation myocardial infarction (NSTEMI) with a new high-sensitivity cardiac troponin I (hs-cTnI) assay on the automated light-initiated chemiluminescent assay (LiCA®) platform.
Methods
Comprehensive analytical validations were performed, and the 99th percentile upper reference limit (URL) from apparently healthy individuals were established. We evaluated the diagnostic performance of the assay for NSTEMI.
Results
The limit of quantitation (LoQ) were 1.9 ng/L (20% CV) and 5.1 ng/L (10% CV). The sex-specific 99th percentile URLs were 17.6 ng/L (4.2% CV) for men (age 20–79y) and 14.2 ng/L (4.9% CV) for women (age 19–89y) in serum, 14.4 ng/L (4.9% CV) for men (age 19–88y) and 12.9 ng/L (5.2% CV) for women (age 19–87y) in plasma, respectively. Detection rates in healthy individuals were from 98.7 to 99.1%. The correlation coefficient and median bias between LiCA and Architect were 0.985 and 0.1% (−2.0–2.9%) in full analytical range of serum specimens. In lower range (<100 ng/L), LiCA had an overall positive bias 6.7% (−1.6–13.3%), R=0.949. At the specific medical decision levels (15.2, 26.2 and 64.0 ng/L), assay difference was estimated to be <10%. No significant differences on AUC, sensitivity and specificity, NPV and PPV were found between LiCA and Architect for the diagnosis of NSTEMI.
Conclusions
LiCA hs-cTnI is a precise, highly sensitive and specific assay that meets the requirement of a 3rd generation (level 4) high-sensitivity method. The diagnostic accuracy of LiCA assay for NSTEMI is comparable to the established Architect hs-cTnI assay.
Funding source: National Major Science and Technology Projects of China
Award Identifier / Grant number: 2017ZX09304012-005
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Research funding: This work was funded by National Major Science and Technology Projects of China (No. 2017ZX09304012-005). The funding organization(s) 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.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Research involving human subjects complied with all relevant national regulation, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and has been approved by the Ethics Committee of Peking University Third Hospital (M2021347).
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Data availability: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-1136).
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