目的 对终点法测定缺血修饰白蛋白(IMA)试剂盒进行性能评价,判断其分析性能是否满足临床要求.方法 应用终点法测定血清中的IMA含量,对试剂盒的线性、精密度和准确度做出评价.结果 质控品的日内CV分别为:低值血清CV=2.12％,高值血清CV =0.48％；日间CV分别为:低值血清CV=2.46％,高值血清CV=2.73％.连续10次测定2个水平的定值质控,得到低值和高值质控的准确率分别为99.95％和99.98％.回收率为99.50％～105.70％.线性试验表明IMA( R2=0.9999)有很好的线性范围.干扰试验表明,溶血、乳糜和黄疸等干扰因素对于IMA测定影响不大.危重病组和急性冠脉综合征(ACS)组的IMA显著低于健康对照组(P＜0.01).结论 该商品化缺血修饰白蛋白(IMA)试剂盒符合实验室性能标准,且灵敏、方便、简单,可批量测定,适用于临床检验.IMA的特异性较好,对于ACS的诊断具有重要意义.%Objective To evaluate the reliability of the commercialization IMA reagent kit by End-point method and to judge whether its analysis performance meets the clinical requirements. Methods The linearity, precision and accuracy were evaluated by the detection of the quantity of IMA in serum through End-point method. Results . The evaluation results showed that the within-run imprecision were respectively 2. 12% and 0. 48% and the within-run imprecision were respectively 2.46% and 2. 73% . The accuracy of the high quality control and the low quality control were 99. 95% and 99. 98% after ten testing. The recovery was 99. 50% -105. 70% . R2 (R2 =0. 9999) of serum dilution curve showed the kit has good linearity. The interference tests showed that hemolysis, chyle and jaundice had little influence for IMA testing. The IMA in critical care group and ACS group were significantly lower than that of control group (P <0.01). Conclusion The commercialization IMA reagent kit fits the laboratory performance standards and it is sensitive, convenient and simple, and can be used for batch testing. It is suitable for clinical testing. IMA has good specificity and is important for diagnosis of ACS.
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