摘要
目的对磁微粒化学发光免疫分析法检测透明质酸(HA)、层黏连蛋白(LN)、Ⅲ型前胶原N端肽(PⅢNP)、Ⅳ型胶原(CⅣ)性能进行评价。方法按照美国临床实验室标准化委员会文件中的方法对批内精密度、日间精密度、线性范围、携带污染率、正确度进行方法学验证。结果批内精密度和日间精密度高,变异系数(CV)<15%;线性范围性能验证结果肝纤四项线性相关系数R^2均>0.99;携带污染率为0.839 2×10^(-5);肝纤四项低浓度的正确度在-0.66%~7.53%之间,高浓度在-0.93%~7.98%之间。结论磁微粒化学发光免疫分析法检测肝纤四项的五大性能指标均符合标准要求。
Objective To investigate the performance of magnetism particulate immuno chemistry luminescence method for detection of hyaluronic acid（HA）, laminin（LN）, typeⅢprocollagen（PCⅢ）, collagen（Ⅳ-C）. Methods Within-batch precision, between-run precision, linear range, carry pollution rate and accuracy were validated accor-ding to the standard documents of NCCLS. Results The result of within-batch precision and between-run precision were well, the index showed coefficient of variation, was less than 15%. Linear ranges of four items of liver fibrosis of the linear cor relation coefficient R2 were greater than 0.99. Carry pollution rate was 0.839 2 ×10-5. Four items of liver fibrosis low concentration of accuracy were between -0.66% and 7.53%, high concentration were between -0.93% and 7.98%. Conclusion The five main performance of magnetism particulate immuno chemistry luminescence method for four items detection of liver fibrosis could achieve the standard requirements.
出处
《实用医技杂志》
2016年第8期819-821,共3页
Journal of Practical Medical Techniques
