两种厂家碱性磷酸酶性能评估

Performance evaluation of alkaline phosphatase from two manufacturers

目的 通过测定灵敏度、信号值、临床相关性比较3种碱性磷酸酶(AP)标记抗-抗体工艺的优劣。方法 用同一种常用的蛋白质标记方法,将碱性磷酸酶和抗促甲状腺激素(TSH)的单抗进行偶联,进一步制成TSH的化学发光法定量测定试剂盒。结果 对用同种标记工艺获得的不同试剂的各项性能指标进行考察,结果厂家S的AP性能最好,信号值最高;而厂家C的两种AP性能较差。结论 从构建的磁微粒TSH检测试剂盒各项性能来看,厂家S的AP经过是本研究推荐的一种可用于化学发光免疫分析的标记物。

【Objective】 To compare the advantages and disadvantages of three alkaline phosphatase(AP) labeled antiantibody technologies by measuring sensitivity,signal value and clinical relevance.【Methods】 Alkaline phosphatase and anti-TSH monoclonal antibody were coupled by the same common protein labeling method,and then the kit for quantitative determination of TSH by chemiluminescence method was made.【Results】 The performance indexes of different reagents obtained by the same labeling process were investigated.The AP of manufacturer S had the best performance and the highest signal value.However,the two AP of manufacturer C have poor performance.【Conclusion】 According to the performance of the magnetic particle TSH detection kit,the AP process of manufacturer S is a recommended marker for chemiluminescence immunoassay in this study.