摘要
目的对五个不同厂家血清胱抑素C(CysC)检测系统的分析性能进行评价和验证。方法采用美国雅培C16000全自动生化分析仪与五个不同厂家胱抑素C试剂组成的检测系统测定血清胱抑素C,评价的方法学性能指标为精密度、线性、抗干扰性及偏倚。结果 CysC浓度在0.9～7.1mg/L时,各厂家试剂总不精密度(CV)<6%。在0.6～5.6mg/L浓度范围,各厂家均有良好的线性范围。血清中一定浓度的胆红素、血红蛋白和乳糜对五个厂家CysC的测定结果产生不同程度的影响,但与厂家声明相符。除利德曼外各厂家的偏倚均小于15%。结论五个厂家CysC试剂的主要分析性能:精密度、线性、抗干扰性、偏倚的验证结果与厂家声明基本一致,但利德曼试剂测定结果与Randox质控品存在偏差。
Objective To evaluate and verify the analytic performance of five different Cystatin C（Cys C） detection kits.Methods Cys C was detected by Abbott C16000 automatic biochemical analyzer and five kinds of Cys C reagent.The precision,linearity,interference and bias of five detection systems were analyzed.Results The total coefficient of variations（CV） of the five reagents were all less than 6% for detecting samples with the concentration of Cys C for 0.9-7.1 mg/L.Within the range of 0.6-5.6 mg/L,the five reagent kits were with good linearity.The detection outcome was interfered to various degree by bilirubin,haematoglobin and chyle,but the interference was consistent with the proclaim of manufacturer.Bias of four kinds of reagents were less than 15%,except for LEADMAN reagent.Conclusion The primary analytic performance,including precision,linearity,interference and bias,of the five kits might be consistent with the analytical performance defined by manufacturer,but there could be with bias between the results of LEADMAN kit and Randox control materials.
出处
《国际检验医学杂志》
CAS
2012年第13期1584-1586,1589,共4页
International Journal of Laboratory Medicine
关键词
胱抑素C
方法学性能
偏倚
Cystatin； methodologic performance； bias
