Konica Minolta Validates a High-Sensitivity Point-of-Care Cardiac Troponin I System
Analytical validation of a surface plasmon-field enhanced fluorescence POC system demonstrated a limit of detection of 0.62 ng/L and measurable hs-cTnI in 66% of healthy individuals, meeting the criteria for a high-sensitivity assay. Sex-specific upper reference limits were established at 20.6 ng/L (males) and 10.7 ng/L (females). This is among the first POC platforms to achieve analytical performance comparable to central-lab high-sensitivity troponin immunoassays.
The original study
Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination.
- Authors
- Braga F, Aloisio E, Panzeri A, Nakagawa T, Panteghini M
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Validation Study
- PMID
- 31622244
Original 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.