应用NCCLS EP10-A2对自建生化检测系统进行初步性能评价  

Preliminary Functional Evaluation of A Home-made Biochemical Detection System According to NCCLS EP10-A2

作　　者：孙宏华[1] 石凌波[1] 康红[1] 胡远明[1] 谢进进[1] 沙瑶[1] 

机构地区：[1]广州中医药大学祈福医院检验科,广州511495

出　　处：《热带医学杂志》2009年第8期951-953,共3页Journal of Tropical Medicine

基　　金：广州番禺区科技局基金(No.2007-Z-74-1)

摘　　要：目的对自建生化检测系统进行初步性能评价。方法依照NCCLS制定的EP10-A2文件,使用自建体系测定血清肌酸激酶(CK)、总胆固醇(Tch)、尿素(Urea)、无机磷(Pi)等四个项目,计算其偏差、总不精密度,及其截距、斜率、非线性、互染率、漂移性,并进行t检验。结果CK、Tch低值、中值、高值偏差及总不精密度均在允许范围内;Urea、Pi低值偏差超过允许偏倚,中值、高值偏差及总不精密度均在允许范围内。CK截距、斜率、非线性、互染率、漂移性均无显著性差异。Tch、Pi截距有显著性差异,Urea斜率有显著性差异;Tch、Urea、Pi非线性、互染率、漂移性均无显著性差异。结论使用自建生化检测体系测定CK、Tch、Urea、Pi,总不精密度均小于1/3 CLIA’88 TEa,互染率较低,稳定性较好;但Urea、Pi低值与标准检测体系存在一定的差距,准确度有待改善。Objective To evaluate the performance of a home-made biochemical testing system. Method The system consists of an OLYMPUS AU 400 biochemical analyzer, Roche c.f.a.s calibrator as well as its non-kit reagents. The testing was performed according to EP10-A2 protocol made by NCCLS to determine the indexes of CK, Tch, Urea and Pi. Their deviations, total imprecision, intercepts, slope rates, nonlinearities, carryover and drifts were calculated. T-test was used for data analysis. Result For measurement of CK, the deviation of low-, mid-, and high-value of Tch were all within the permissive ranges. There were no significant difference between their intercepts, slope rates, nonlinearities, carryover, and drifts. For the Urea, the low value deviation was beyond of permissive range while the mid and high values as well as total imprecision were in the permissive ranges. There were significant difference between the slope rates and no significant difference between their intercepts, nonlinearities, carryover, and drifts. For Pi, the low value deviation was beyond of permissive range while mid and high values as well as total imprecision were in the permissive ranges. There were significant difference between their intercepts and no significant difference between their slope rates, nonlinearities, carryover, and drifts. Conclusion The total imprecision were all less than 1/3 CLIA＇ 88 TEa, with lower carryover and better stability. Further improvement, especially the urea measurement and low Pi value, is required.

关 键 词：EP10-A2 自建检测系统 初步评价 

分 类 号：R446.69[医药卫生—诊断学]