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

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) w...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clinical biochemistry 2010-08, Vol.43 (12), p.998-1002
Hauptverfasser: Arrebola, M.M., Lillo, J.A., Diez De Los Ríos, M.J., Rodríguez, M., Dayaldasani, A., Yahyaoui, R., Pérez, V.
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung: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.
ISSN:0009-9120
1873-2933
DOI:10.1016/j.clinbiochem.2010.04.073