中国ARCHITECT高敏肌钙蛋白I多中心研究启动

2013-07-02 幽草 整理 cmt

  2013年6月14日,中国ARCHITECT高敏肌钙蛋白I多中心研究启动会在上海举行。加拿大麦克马斯特(McMaster)大学卡瓦萨克(Peter Kavsak)教授、上海长征医院仲人前教授、北京大学人民医院许俊堂教授担任大会讲者,与参会专家共同探讨了高敏肌钙蛋白的研究进展与应用展望。   Kavsak 教授主要介绍了国外高敏肌钙蛋白应用的现状。阿普尔

  2013年6月14日,中国ARCHITECT高敏肌钙蛋白I多中心研究启动会在上海举行。加拿大麦克马斯特(McMaster)大学卡瓦萨克(Peter Kavsak)教授、上海长征医院仲人前教授、北京大学人民医院许俊堂教授担任大会讲者,与参会专家共同探讨了高敏肌钙蛋白的研究进展与应用展望。

  Kavsak 教授主要介绍了国外高敏肌钙蛋白应用的现状。阿普尔(Apple)在《临床化学杂志》发表观点指出:根据所用检测方法在低于第99百分位值时可检出的表观健康人群比例作为高敏肌钙蛋白的判断标准:在低于第99 百分位值时能检出<50%表观健康人群的方法为“常规”心肌肌钙蛋白检测方法;能检出50%~75%表观健康人群的方法为第一代高敏肌钙蛋白检测方法,能检出75%~95%表观健康人员的方法为第二代检测方法,能检出>95%表观健康人群的方法为第三代检测方法。研究提示,目前常用的品牌试剂中,罗氏高敏肌钙蛋白T可以检测出25%的表观健康人群,雅培高敏肌钙蛋白I能检测出96%的表观健康人群[Clin Chem2012, 58(11): 1574];前者第99 百分位值的变异系数(CV)为8%;后者则为5.6%[Clin Chem 2012, 58(1): 54]。

  许俊堂教授在谈到高敏肌钙蛋白对于临床带来的挑战和机遇时强调,肌钙蛋白是已被广泛认可的疑似急性冠脉综合征患者危险分层及心肌梗死诊断的首选生物标志物,同时需要选用肌钙蛋白第99百分位值作为截断值。高敏肌钙蛋白可检测轻微的心肌损伤,可帮助临床更早诊断及决定治疗方案。解决高敏肌钙蛋白临床特异性问题需要密切结合临床症状、心电图变化,同时需要动态观察肌钙蛋白以可靠地排除心肌梗死、提高阳性预测值、增加特异性及排除非缺血性心肌坏死。

  仲人前教授简要介绍了雅培ARCHITECT高敏肌钙蛋白I检测试剂在中国人群中的分析性能研究。此研究由上海长征医院牵头进行,预计将入组超过1500名正常人,入组人群覆盖全国8 个省市。研究拟分析的数据包括正常人群ARCHITECT高敏肌钙蛋白I第99百分位值及其对应的CV 值、10%CV值及介于最低检测限与第99 百分位值之间的正常人群检出比例。研究旨在了解新一代ARCHITECT 高敏肌钙蛋白I在中国人群中国的分析性能,建立基于中国人群的参考值范围,为临床应用提供更可信的本地数据支持。(幽草整理,Kavsak教授审校)  

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    2021-03-04 ms5233340938792882

    学习咯

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    2013-09-10 yuandd
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    2013-10-27 shock_melon
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