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医院体外诊断试剂选择方法探讨 被引量:1

The exploration of the selection methods for IVD
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摘要 目的为选择性价比高的β-羟丁酸测定试剂,针对3家不同试剂生产厂家的试剂进行了主要性能评估和对比分析。方法分别对2个厂家的试剂进行主要性能评价,并与国际优质的英国朗道试剂进行对比。结果国内厂家的β-羟丁酸试剂在稳定性、线性范围、临床比对、精密度、抗脂浊干扰、灵敏度方面都符合要求,与进口的英国朗道试剂有良好的相关性。结论新成生物的β-羟丁酸测定试剂盒符合临床应用要求。 Objective In order to select the cost-effective of β-HB,to analyze and contrast the main performance evaluation of reagents of three different reagent production manufacturers.Methods Performances of two major reagents from manufacturers were evaluated,which were compared with the international quality of British lang way reagents.Results The domestic manufacturers β-HB reagents′ stability,linear range,clinical analyze,precision,interference,sensitivity were in line with the import requirements of Japan′s bio-research reagent and also had good correlation.Conclusion The performance of the domestic β-HB reagent is fully meet the clinical applications.
作者 宿炳林
出处 《检验医学与临床》 CAS 2012年第21期2674-2675,共2页 Laboratory Medicine and Clinic
关键词 Β-羟丁酸 精密度 临床比对 稳定性 线性范围 D-3-hydroxybutyatre precision clinical analyze stability linear range
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