Evaluation of the new ImmuliteTurbo cTnI assay and the original immulite cTnI assay.
OBJECTIVE
An analytical and clinical evaluation of cTnI on the ImmuliteTurbo system with 15 min assay time compared to 45 min with the original Immulite assay is presented.


METHODS
Detection limit, functional sensitivity, AMI decision limit, assay linearity, influence of sample material (serum, heparin, citrate and EDTA plasma), interference, analytical and clinical method comparison studies were performed.


RESULTS
Functional sensitivity (at CV 20%) was 0.35 compared to 0.23 microg/L for the original assay. AMI decision limit (99th percentile of a reference control group) was 0.48 microg/L for both assays. In patients with acute coronary syndromes, chronic renal failure or pulmonary embolism the assays showed concordant results in 87.2-96.5%. Differing results were only found around the cut-off level and were attributed to assay imprecision.


CONCLUSIONS
The new assay is sensitive for the determination of cTnI, shows comparable results to the original assay version and is easy to perform within 15 min.
Peetz
D
D
Institute of Clinical Chemistry and Laboratory Medicine, University Hospital, Mainz, Germany. peetz@zentrallabor.klinik.uni-mainz.de
Erbes
H
H
Hafner
G
G
D000293:Adolescent; D000328:Adult; D000789:Angina, Unstable / Q000175:diagnosis*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis*; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000032:analysis*
D019210:Troponin I