摘要
目的探讨应用新鲜冰冻血浆作为国产TC、TG试剂校准品,建立血脂分析系统的可行性。方法按照EP 9-A文件要求和NCEP目标计划,以罗氏系统测定的新鲜血清结果为参考,将其准确度传递到以新鲜混合冰冻血浆为校准品的国产乙试剂/日立7170A的临时分析系统上。结果临时分析系统测定偏差TC:5.82,-0.21,-0.98;TG:20.17,4.79,1.77。TC、TG在中、高水平EA>预期偏差95%可信区间上限,偏差、预期偏差能够被NCEP目标接受。结论可以将罗氏系统测定结果通过新鲜混合冰冻血浆传递,建立可比对国产血脂试剂分析系统。
Objective To discuss feasibility of establishing a Homemade reagent/fresh refrigerated plasma calibration/Hitachi 7170A analysis system which using fresh refrigerated plasma as calibrater of Homemade TC ＆ TG reagent. Methods According to the profile of EP9-A and NCEP target program,using fresh serum results determined by Roche system as the reference,the accuracy was transferred to Homemade Reagent/Hitachi 7170A Temporary Analysis System which used fresh mixed refrigrated plasma as calibrator. Results Determination bias of TC were, 5.82,-0.21 ,-0. 98 and those of TG were：20.17,4.79,1.77 in Temporary System. The EA of medium and high levels of both TC and TG of the 95% confidence interval of expected bias 〉upper limit of the 95% confidence interval of expected bias. Both bias and expected bias were acceptable to NCEP target. Conclusion Comparable blood lipid analysis system which uses Homemade reagent,and uses fresh plasma as calibrator can be established through accuracy transfer.
出处
《现代检验医学杂志》
CAS
2006年第5期39-41,共3页
Journal of Modern Laboratory Medicine
关键词
罗氏系统
准确度传递
血脂
血浆
Roche System
accuracy transfer
blood lipid
blood plasma
