Analytical performance of a sensitive assay for cardiac troponin I with loci™ technology

• Published in: Clinical biochemistry 2010-08, Vol.43 (12), p.998-1002
• Main Authors: Arrebola, M.M., Lillo, J.A., Diez De Los Ríos, M.J., Rodríguez, M., Dayaldasani, A., Yahyaoui, R., Pérez, V.
• Format: Article
• Language: English
• Subjects: Acute coronary syndrome; Acute Coronary Syndrome - blood; Adolescent; Adult; Aged; Biological and medical sciences; Biological Assay - methods; Cardiology. Vascular system; Cardiovascular system; Coronary heart disease; Female; Heart; Humans; Investigative techniques, diagnostic techniques (general aspects); Limit of Detection; LOCI technology; Male; Medical sciences; Middle Aged; Myocarditis. Cardiomyopathies; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Reference Values; Reproducibility of Results; Rheumatoid Factor - blood; Troponin I; Troponin I - blood; Young Adult
• ISSN: 0009-9120; 1873-2933
• DOI: 10.1016/j.clinbiochem.2010.04.073

To confirm the analytical performance of the Dimension Vista LOCI troponin I assay (cTnI). Limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ) with a 10% coefficient of variation (CV), linearity, precision, method comparison, and 99th percentile upper reference limits (URL) were analyzed. Endogenous analytes and rheumatoid factor (RF) were tested for assay interference. The 99th percentile was 0.022 µg/L (CV = 14%) and the LoQ was 0.036 µg/L. The ratio of 10% CV concentration to 99th percentile was 1.63. Linearity extended from 0 to 44.36 µg/L. The method comparison equation was Dimension® Vista™ = 0.94 (Dimension® RxL) + 0.00 µg/L with bias at low levels. No interference was detected. This study shows acceptable performance characteristics of the LOCI cTnI assay on Dimension® Vista™ to diagnosis and risk stratification of patients with acute coronary syndrome symptoms.