Ultrasensitive quantification of cardiac troponin I by a Single Molecule Counting method: analytical validation and biological features
Por:
Garcia-Osuna, A, Gaze, D, Grau-Agrarnunt, M, Morris, T, Telha, C, Bartolome, A, Bishop, JJ, Monsalve, L, Livingston, R, Estis, J, Nolan, N, Sandlund, J, Ordonez-Llanos, J
Publicada:
1 nov 2018
Resumen:
Aim: To evaluate analytical and biological characteristics of the Singulex Clarity (R) cTnI assay, based upon Single Molecule Counting technology.
Methods: 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.
Results: 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.
Conclusions: 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.
Filiaciones:
Garcia-Osuna, A:
IIB Hosp St Pau, Dept Clin Biochem, Barcelona, Spain
Gaze, D:
Univ Westminster, Dept Biomed Sci, London, England
St Georges Univ Hosp NHS Fdn Trust, Dept Clin Blood Sci, London, England
Grau-Agrarnunt, M:
IIB Hosp St Pau, Dept Clin Biochem, Barcelona, Spain
Morris, T:
St Georges Univ Hosp NHS Fdn Trust, Dept Clin Blood Sci, London, England
Telha, C:
St Georges Univ Hosp NHS Fdn Trust, Dept Clin Blood Sci, London, England
Bartolome, A:
Singulex Inc, Alameda, CA USA
Bishop, JJ:
Singulex Inc, Alameda, CA USA
Monsalve, L:
Singulex Inc, Alameda, CA USA
Livingston, R:
Singulex Inc, Alameda, CA USA
Estis, J:
Singulex Inc, Alameda, CA USA
Nolan, N:
Singulex Inc, Alameda, CA USA
Sandlund, J:
Singulex Inc, Alameda, CA USA
Ordonez-Llanos, J:
IIB Hosp St Pau, Dept Clin Biochem, Barcelona, Spain
Univ Autonoma Barcelona, Dept Biochem & Mol Biol, Barcelona, Spain
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