Saadeddin Salam, Habbab Mohammed, Siddieg Hisham, Fayomi Mahmoud, Dafterdar Rofaida
Department of Pathology, Riyadh Armed Forces Hospital, Riyadh, Kingdom of Saudi Arabia.
Med Sci Monit. 2004 Mar;10(3):MT43-6. Epub 2004 Mar 1.
A rapid bedside whole-blood quantitative cTnT assay has recently been developed. We evaluated the reliability of this test for the diagnosis of myocardial injury in patients with acute coronary syndrome (ACS).
MATERIAL/METHODS: Whole-blood cTnT levels were measured in 96 patients with ACS using the Roche Cardiac Reader(R) rapid bedside assay device, and the results were compared with serum cTnT levels in the same patients measured by the Roche Elecsys(R) Immunoanalyzer. There were 50 patients with clinical evidence of myocardial injury and 56 without.
From the qualitative point of view (reporting negative or positive tests), the results of the rapid bedside tests were identical to those obtained by the serum immunoanalyzer. From quantitative the point of view, the rapid bedside tests could not measure exact values below 0.1 ng/ml (reported negative) or above 2.0 ng/ml (reported >2.0). The measurements made by the rapid bedside tests within the range of 0.1 to 2.0 ng/ml correlated well with those of the serum immunoanalyzer (Cardiac Reader(R) cTnT=0.61, Elecsys(R) cTnT+0.12; r=0.88), but their mean values were significantly lower (1.20I0.71 vs. 1.41I1.03, p=0.0007).
The rapid bedside cTnT assay correlates well with immunoanalyzer measurements between the values of 0.1 and 2.0 ng/ml. However, they tend to give significantly lower values and fail to give exact values below 0.1 and above 2.0 ng/ml, which may affect their performance in monitoring and managing patients with ACS, and limit their use in predicting outcome.
最近开发了一种快速床旁全血定量cTnT检测方法。我们评估了该检测方法在急性冠状动脉综合征（ACS）患者心肌损伤诊断中的可靠性。
材料/方法：使用罗氏心脏检测仪（Roche Cardiac Reader(R)）快速床旁检测设备对96例ACS患者的全血cTnT水平进行检测，并将结果与通过罗氏电化学发光免疫分析仪（Roche Elecsys(R) Immunoanalyzer）检测的同一患者的血清cTnT水平进行比较。其中有50例有心肌损伤临床证据的患者和56例无心肌损伤临床证据的患者。
从定性角度（报告检测结果为阴性或阳性）来看，快速床旁检测结果与血清免疫分析仪获得的结果一致。从定量角度来看，快速床旁检测无法测量低于0.1 ng/ml（报告为阴性）或高于2.0 ng/ml（报告为>2.0）的准确值。快速床旁检测在0.1至2.0 ng/ml范围内的测量结果与血清免疫分析仪的测量结果相关性良好（心脏检测仪（Roche Cardiac Reader(R)）cTnT = 0.61，电化学发光免疫分析仪（Roche Elecsys(R)）cTnT + 0.12；r = 0.88），但其平均值显著较低（1.20±0.71 vs. 1.41±1.03，p = 0.0007）。
快速床旁cTnT检测在0.1至2.0 ng/ml的值之间与免疫分析仪测量结果相关性良好。然而，它们往往给出的值显著较低，并且无法给出低于0.1和高于2.0 ng/ml的准确值，这可能会影响其在ACS患者监测和管理中的性能，并限制其在预测预后方面的应用。
