Analytical Validation of a High-Sensitivity Cardiac Troponin T Assay
Analytical Validation of a High-Sensitivity Cardiac Troponin T Assay
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DOI：
10.1373/clinchem.2009.132654
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发表时间：
2010-02-01
影响因子：
9.3
通讯作者：
Katus, Hugo A.
中科院分区：
文献类型：
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作者：
Giannitsis, Evangelos;Kurz, Kerstin;Katus, Hugo A.
背景技术背景：我们报告了一种新的高灵敏度的心肌肌钙蛋白T（hs-cTnT）测定，罗氏第四代cTnT测定的修改，和验证的分析性能，此assay.METHODS：验证包括测试的分析灵敏度，特异性，干扰和精密度。我们从健康参考人群（n = 616）中确定了第99百分位数临界值。此外，我们研究了在确诊为非ST段抬高型心肌梗死（non-STEMI）的患者中使用hs-cTnT与cTnT系列测量时，阳性结果的时间差异。在第99百分位数值13.5 ng/L时，使用Elecsys（R）2010分析仪的CV为9%。该检测试剂盒对cTnT具有特异性，不受人cTnI或cTnC、骨骼肌TnT或血红蛋白浓度高达1000 mg/L的干扰，高于该浓度时预期会出现假性低值。当对该检测进行临床评价时，与cTnT相比，hs-cTnT高于第99百分位数浓度识别出就诊时患有非STEMI的患者数量显著更高（45 vs 20例患者，P = 0.0004），并且在连续采样后，在另外9例患者（55 vs 46例患者，P = 0.23）中进行了非STEMI的最终诊断。与cTnT相比，hs-cTnT的诊断时间显著缩短[分别为平均71.5（SD 108.7）min vs 246.9（82.0）min; P < 0.01]。结论：hs-cTnT的分析性能符合ESC-ACCF-AHA-WHF全球工作组关于心肌梗死诊断的建议。(C)2009年美国临床化学协会
BACKGROUND: We report the development of a novel high-sensitivity cardiac troponin T (hs-cTnT) assay, a modification of the Roche fourth-generation cTnT assay, and validation of the analytical performance of this assay.METHODS: Validation included testing of analytical sensitivity, specificity, interferences, and precision. We established the 99th percentile cutoff from healthy reference populations (n = 616). In addition, we studied differences in time to a positive result when using serial measurements of hs-cTnT vs cTnT in patients with a confirmed diagnosis of non-ST elevation myocardial infarction (non-STEMI).RESULTS: The hs-cTnT assay had an analytical range from 3 to 10 000 ng/L. At the 99th percentile value of 13.5 ng/L, the CV was 9% using the Elecsys (R) 2010 analyzer. The assay was specific for cTnT without interferences from human cTnI or cTnC, skeletal muscle TnT, or hemoglobin concentrations up to 1000 mg/L, above which falsely lower values would be expected. When the assay was evaluated clinically, a hs-cTnT higher than the 99th percentile concentration identified a significantly higher number of patients with non-STEMI on presentation (45 vs 20 patients, P = 0.0004) compared with cTnT, and a final diagnosis of non-STEMI was made in 9 additional patients (55 vs 46 patients, P = 0.23) after serial sampling. Time to diagnosis was significantly shorter using hs-cTnT compared with cTnT [mean 71.5 (SD 108.7) min vs 246.9 (82.0) min, respectively; P < 0.01].CONCLUSIONS: The analytical performance of hs-cTnT complies with the ESC-ACCF-AHA-WHF Global Task Force recommendations for use in the diagnosis of MI. (C) 2009 American Association for Clinical Chemistry