Analytical performance of a sensitive assay for cardiac troponin I with loci technology.
OBJECTIVE
To confirm the analytical performance of the Dimension Vista LOCI troponin I assay (cTnI).


METHODS
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.
Arrebola
M M
MM
Department of Biochemistry and Core Laboratory, Carlos Haya Regional University Hospital, Avda Carlos Haya s/n, 29010 Málaga, Spain. arrebola99@yahoo.es
Lillo
J A
JA
Diez De Los Ríos
M J
MJ
Rodríguez
M
M
Dayaldasani
A
A
Yahyaoui
R
R
Pérez
V
V
D054058:Acute Coronary Syndrome / Q000097:blood*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001681:Biological Assay / Q000379:methods*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D015203:Reproducibility of Results; D012217:Rheumatoid Factor / Q000097:blood; D019210:Troponin I / Q000097:blood*; D055815:Young Adult
D019210:Troponin I; D012217:Rheumatoid Factor