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Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination

  • Federica Braga EMAIL logo , Elena Aloisio , Andrea Panzeri , Takahito Nakagawa and Mauro Panteghini
Published/Copyright: October 17, 2019
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 58 Issue 1

Abstract

Background

Highly sensitive cardiac troponin assays (hs-cTn) are not available as point-of-care (POC) measurements. As rapid testing cannot be achieved at the expense of clinical performance, there is an urgent need to develop and rigorously validate POC hs-cTn. Konica Minolta (KM) has recently developed a surface plasmon-field enhanced fluorescence spectroscopy-based POC hs-cTn I system.

Methods

We validated the analytical characteristics of the KM POC system according to the international guidelines.

Results

Limit of blank (LoB) and limit of detection (LoD) were 0.35 and 0.62 ng/L, respectively, hs-cTn I concentrations corresponding to a total CV of 20%, 10% and 5% were 1.5, 3.9 and 11.0 ng/L, respectively. Method comparison studies showed that KM calibration was successfully traced to higher-order references. Limit of quantitation (LoQ), i.e. the hs-cTn I concentration having a total error of measurement of ≤34%, was 10.0 ng/L. The upper reference limit (URL) for 600 healthy blood donors was calculated at 12.2 ng/L (90% confidence interval [CI]: 9.2–39.2), while sex-partitioned URLs were 20.6 (males) and 10.7 ng/L (females), respectively (p < 0.0001). KM assay measured hs-cTn I concentrations >LoD in 65.7% of all reference individuals, in 76.7% of males and in 54.7% of females, respectively.

Conclusions

The KM system joins the characteristics of POC systems to the analytical performance of hs-cTn.

Keywords: high sensitivity troponin; method evaluation; point of care testing

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

  2. Research funding: Supported by an Institutional grant by Konica Minolta.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: 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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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0801).

Received: 2019-08-01
Accepted: 2019-09-22
Published Online: 2019-10-17
Published in Print: 2019-12-18

©2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2019-0801
Keywords for this article
high sensitivity troponin; method evaluation; point of care testing

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Reflex TSH strategy: the good, the bad and the ugly
  4. Review
  5. Shortcomings in the evaluation of biomarkers in ovarian cancer: a systematic review
  6. Mini Review
  7. Clinical application of presepsin as diagnostic biomarker of infection: overview and updates
  8. Opinion Paper
  9. Gut microbiotas and immune checkpoint inhibitor therapy response: a causal or coincidental relationship?
  10. EFLM Paper
  11. Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters
  12. General Clinical Chemistry and Laboratory Medicine
  13. Pre-, post- or no acidification of urine samples for calcium analysis: does it matter?
  14. Pre-analytical and analytical confounders of serum calprotectin as a biomarker in rheumatoid arthritis
  15. Dynamics of soluble syndecan-1 in maternal serum during and after pregnancies complicated by preeclampsia: a nested case control study
  16. Multi-site performance evaluation and Sigma metrics of 20 assays on the Atellica chemistry and immunoassay analyzers
  17. Plasma creatinine medians from patients partitioned by gender and age used as a tool for assessment of analytical stability at different concentrations
  18. Two-center comparison of 10 fully-automated commercial procalcitonin (PCT) immunoassays
  19. Method comparison of four clinically available assays for serum free light chain analysis
  20. Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone
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