Ultrasensitive quantification of cardiac troponin I by a Single Molecule Counting method: analytical validation and biological features
2018; Elsevier BV; Volume: 486; Linguagem: Inglês
10.1016/j.cca.2018.08.015
ISSN1873-3492
AutoresÁlvaro García‐Osuna, David Gaze, M. Grau-Agramunt, Thomas Morris, Catarina Telha, Amelita Bartolome, Jeffrey J. Bishop, Luis Monsalve, Richard Livingston, Joel Estis, Niamh Nolan, Johanna Sandlund, Jordi Ordóñez‐Llanos,
Tópico(s)Integrated Circuits and Semiconductor Failure Analysis
ResumoTo evaluate analytical and biological characteristics of the Singulex Clarity® cTnI assay, based upon Single Molecule Counting technology. Assay's analytical sensitivity, precision, linearity, hook effect, cross-reactivity or interference by endogenous and exogenous substances, stability, 99th reference percentile [p99th] in EDTA plasma were evaluated in single or multi-site studies. Detection limit was 0.12 ng/L. Sensitivity was 0.14 ng/L at 20% CV (functional sensitivity) and 0.53 ng/L at 10% CV. Imprecision was 3.16%–10.0% in a multi-lot, single-site study, and 5.5%–12.0% in a single-lot, multi-site study; assay was linear from 0.08 to 25,000 ng/L. No hook effect was observed; any cross-reactivity/interference exceeded the 10%. Healthy subjects were recruited using clinical history, normal NT-proBNP and eGFR (n = 560) or plasma creatinine (n = 535) as inclusion criteria. cTnI was detectable in 96.8% of healthy subjects. The p99th were 8.01 (eGFR used) and 8.15 ng/L (plasma creatinine); both were measured with ≤5.7% CV. Median cTnI were significantly higher in older and male than in young and female subjects. The Singulex Clarity cTnI assay show analytical features and % detection in healthy subjects that improve the corresponding values of most of the existing high-sensitivity cTnI assays.
Referência(s)