Multicenter evaluation of analytical performance of the Liaison troponin I assay.
OBJECTIVE
This study evaluated the analytical characteristics of the Liaison immunoassay for cardiac troponin I (cTnI).


METHODS
The protocol consisted of eight sections: evaluation of antibody specificity, linearity, detection limit and imprecision, method comparison, evaluation of endogenous interferents, anticoagulant interference, sample stability, and reference values.


RESULTS
The assay equally measured free and complexed cTnI. The minimum detectable cTnI concentration was 0.021 microg/l. The cTnI concentration corresponding to a total CV of 10% was 0.056 microg/l. Linearity of response was demonstrated along the entire dynamic range of the assay. Assay interferences were minimal. cTnI concentrations in serum and heparinized plasma were significantly different. Values in EDTA plasma were on average approximately 5% higher than in matched serum, but this difference was not significant. The 99th percentile cTnI value in healthy subjects was 0.036 microg/l.


CONCLUSIONS
Being sensitive, specific, and precise, the Liaison cTnI assay meets current requirements to aid in the diagnosis of myocardial necrosis.
Pagani
Franca
F
Laboratorio Analisi Chimico Cliniche 1, Azienda Ospedaliera Spedali Civili, Brescia 25125, Italy.
Stefini
Francesca
F
Chapelle
Jean-Paul
JP
Lefèvre
Guillaume
G
Graïne
Hanafi
H
Luthe
Hilmar
H
Engelmayer
Jutta
J
Panteghini
Mauro
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric; D019210:Troponin I / Q000097:blood*
D019210:Troponin I