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Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination
| Content Provider | Scilit |
|---|---|
| Author | Braga, Federica Aloisio, Elena Panzeri, Andrea Nakagawa, Takahito Panteghini, Mauro |
| Copyright Year | 2019 |
| Description | 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. |
| Related Links | http://www.degruyter.com/downloadpdf/j/cclm.ahead-of-print/cclm-2019-0801/cclm-2019-0801.xml |
| Ending Page | 145 |
| Page Count | 8 |
| Starting Page | 138 |
| ISSN | 14346621 |
| e-ISSN | 14374331 |
| DOI | 10.1515/cclm-2019-0801 |
| Journal | Clinical Chemistry and Laboratory Medicine (CCLM) |
| Issue Number | 1 |
| Volume Number | 58 |
| Language | English |
| Publisher | Walter de Gruyter GmbH |
| Publisher Date | 2019-08-24 |
| Access Restriction | Open |
| Subject Keyword | Clinical Chemistry and Laboratory Medicine (cclm) Medical Laboratory Technology High Sensitivity Troponin Method Evaluation Point of Care Testing Journal: Clinical Chemistry and Laboratory Medicine (cclm), Vol- 58 |
| Content Type | Text |
| Resource Type | Article |
| Subject | Biochemistry (medical) Clinical Biochemistry |
