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

Federica Braga 1 , 2 , Elena Aloisio 1 , 3 , Andrea Panzeri 1 , 3 , Takahito Nakagawa 4  and Mauro Panteghini 1 , 3
  • 1 Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, Università di Milano, Milan, Italy
  • 2 UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157 Milano, Italy
  • 3 UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Milano, Italy
  • 4 Konica Minolta, Inc., Project Promotion Department, Product Planning Division, Precision Medicine Business Unit, Tokyo, Japan
Federica Braga
  • Corresponding author
  • Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, Università di Milano, Milan, Italy
  • UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157 Milano, Italy
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, Elena Aloisio
  • Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, Università di Milano, Milan, Italy
  • UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Milano, Italy
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, Andrea Panzeri
  • Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, Università di Milano, Milan, Italy
  • UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Milano, Italy
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, Takahito Nakagawa
  • Konica Minolta, Inc., Project Promotion Department, Product Planning Division, Precision Medicine Business Unit, Tokyo, Japan
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and Mauro Panteghini
  • Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, Università di Milano, Milan, Italy
  • UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Milano, Italy
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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.

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Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.

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