Casals Gregori, Filella Xavier, Bedini Josep Lluis
Department of Biochemistry and Molecular Genetics and Core Laboratory (CDB), Hospital Clínic, C/Villaroel, 170, 08036 Barcelona, Catalonia, Spain.
Clin Biochem. 2007 Dec;40(18):1406-13. doi: 10.1016/j.clinbiochem.2007.08.012. Epub 2007 Aug 29.
We evaluated the analytical and clinical performance of a new ultrasensitive cardiac troponin I assay (cTnI) on the ADVIA Centaur system (TnI-Ultra).
The evaluation included the determination of detection limit, within-assay and between-assay variation and comparison with two other non-ultrasensitive methods. Moreover, cTnI was determined in 120 patients with acute chest pain with three methods. To evaluate the ability of the new method to detect MI earlier, it was assayed in 8 MI patients who first tested negative then positive by the other methods.
The detection limit was 0.009 microg/L and imprecision was <10% at all concentrations evaluated. In comparison with two other methods, 10% of the anginas diagnosed were recategorized to MI.
The ADVIA Centaur TnI-Ultra assay presented high reproducibility and high sensitivity. The use of the recommended lower cutpoint (0.044 microg/L) implied an increased and earlier identification of MI.
我们评估了ADVIA Centaur系统上一种新型超敏心肌肌钙蛋白I检测方法（cTnI）（TnI-Ultra）的分析性能和临床性能。
评估内容包括检测限的测定、批内和批间变异，并与其他两种非超敏方法进行比较。此外，用三种方法对120例急性胸痛患者测定了cTnI。为评估新方法更早检测出心肌梗死的能力，对8例最初检测为阴性而后其他方法检测为阳性的心肌梗死患者进行了检测。
检测限为0.009μg/L，在所评估的所有浓度下不精密度均<10%。与其他两种方法相比，10%诊断为心绞痛的患者被重新分类为心肌梗死。
ADVIA Centaur TnI-Ultra检测方法具有高重现性和高灵敏度。使用推荐的较低切点（0.044μg/L）意味着能更早且更多地识别出心肌梗死。
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