Objectives: To confirm the analytical performance of the Dimension Vista LOCI troponin I assay (cTnI).
Design and method: 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.
Results: The 99th percentile was 0.022 microg/L (CV=14%) and the LoQ was 0.036 microg/L. The ratio of 10% CV concentration to 99th percentile was 1.63. Linearity extended from 0 to 44.36 microg/L. The method comparison equation was Dimension(R) Vista=0.94 (Dimension RxL)+0.00 microg/L with bias at low levels. No interference was detected.
Conclusions: 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.
2010. Published by Elsevier Inc.