TY - JOUR
T1 - Performance of the Advia Centaur second generation troponin assay TnI-Ultra compared to the first generation cTnI assay
AU - van de Kerkhof, D.H.
AU - Peters, B.
AU - Scharnhorst, V.
PY - 2008
Y1 - 2008
N2 - BACKGROUND:
A cardiac troponin concentration above the 99th percentile limit of a reference population is a sensitive marker of myocardial necrosis. Current guidelines require troponin assays to have a total imprecision of <or =10% at the 99th percentile limit. In this study, the Advia Centaur second-generation TnI-Ultra assay was validated and compared with its predecessor the cardiac troponin I (cTnI) assay, with a focus on the current guidelines for diagnosis of acute myocardial damage.
METHODS:
An imprecision profile of the TnI-Ultra assay was evaluated by analysing different pools over 20 days. The imprecision of the cTnI assay was used as comparison. The reference range was established based on TnI-Ultra analysis in 221 individuals.
RESULTS:
The cTnI concentration that could be determined with a total imprecision of 10% was 0.05 microg/L for the TnI-Ultra assay and 0.3 microg/L for the cTnI assay. The 99th percentile limit in the distribution of a reference population was 0.06 microg/L as determined with the TnI-Ultra assay.
CONCLUSIONS:
The TnI-Ultra assay provides significantly improved sensitivity when compared with the cTnI assay and a total imprecision of <or =10% is obtained at the 99th percentile limit of value distribution of a reference population. Using the TnI-Ultra assay, slightly increased cTnI concentration can be detected reliably following the current guidelines.
AB - BACKGROUND:
A cardiac troponin concentration above the 99th percentile limit of a reference population is a sensitive marker of myocardial necrosis. Current guidelines require troponin assays to have a total imprecision of <or =10% at the 99th percentile limit. In this study, the Advia Centaur second-generation TnI-Ultra assay was validated and compared with its predecessor the cardiac troponin I (cTnI) assay, with a focus on the current guidelines for diagnosis of acute myocardial damage.
METHODS:
An imprecision profile of the TnI-Ultra assay was evaluated by analysing different pools over 20 days. The imprecision of the cTnI assay was used as comparison. The reference range was established based on TnI-Ultra analysis in 221 individuals.
RESULTS:
The cTnI concentration that could be determined with a total imprecision of 10% was 0.05 microg/L for the TnI-Ultra assay and 0.3 microg/L for the cTnI assay. The 99th percentile limit in the distribution of a reference population was 0.06 microg/L as determined with the TnI-Ultra assay.
CONCLUSIONS:
The TnI-Ultra assay provides significantly improved sensitivity when compared with the cTnI assay and a total imprecision of <or =10% is obtained at the 99th percentile limit of value distribution of a reference population. Using the TnI-Ultra assay, slightly increased cTnI concentration can be detected reliably following the current guidelines.
U2 - 10.1258/acb.2007.007209
DO - 10.1258/acb.2007.007209
M3 - Article
C2 - 18482922
SN - 0004-5632
VL - 45
SP - 316
EP - 317
JO - Annals of Clinical Biochemistry
JF - Annals of Clinical Biochemistry
IS - 3
ER -