摘要
目的应用参考方法赋值冰冻新鲜人血清样本作为校准品,观察可否改善测量结果的准确性和一致性。方法由国内2家参考实验室按IFCC推荐的参考测量程序为冰冻新鲜混合人血清赋值,各实验室在赋值血清校准前,重复检测赋值血清、水平1样本（S1）和水平2样本（S2）各3次;再用赋值血清校准常规检测系统,校准后再重复校准前测量,记录并收集实验数据。比较校准前后,不同检测系统间总胆固醇（TC）、三酰甘油（TG）测定结果的变异和测量结果与参考方法测量结果间的偏移。结果 TC和TG的复现性（CV）由校准前的7.01%～3.16%下降到校准后的2.34%～1.85%;偏移则从3.08%～0.88%下降到1.07%～0.33%。校准前TC项目符合质量要求的临床实验室有7家,符合率为33.3%,校准后符合率为71.4%;校准前TG项目符合质量要求的临床实验室有11家,符合率为52.4%,校准后符合率为95.2%。结论参考方法赋值的冰冻新鲜人血清校准临床常规检测系统具有可行性,可改善和提高常规检测系统测定结果的准确性和可比性。
Objective To observe whether the measurement accuracy and consistency can be improved by applying frozen fresh human serum samples assigned by reference method as calibrator. Methods The value of frozen fresh human serum mixture was assigned according to the IFCC- recommended reference measurement procedures by two reference laboratories in China. Each lab performed repeated tests of the assignment serum samples,level 1（ S1） and level 2（ S2）samples 3 times before calibration,in which the assigned serum was used on the routine detection system. After calibration,samples were detected in the same manner before calibration and experimental data were recorded. Variation of total cholesterol（ TC） and triglyceride（ TG） before and after and calibration measured by different detection systems were compared,as well as the bias from reference method. Results After calibration,the reproducibility of TC and TG（ CV） decreased from 7. 01%- 3. 16% to 2. 34%- 1. 85%,and the deviation decreased from 3. 08%- 0. 88% to 1. 07%-0. 33%. Before calibration,there were only seven clinical laboratories in which the TC item meets the quality criteria,with a coincidence rate of 33. 3%. After calibration,the coincidence rate increased to 71. 4%. And there were eleven clinical laboratories in which the TG item meets the criteria,with a coincidence rate of 52. 4%. After calibration,the coincidence rate was 95. 2%. Conclusion Reference method for the assignment of frozen fresh human serum calibration is feasible for routine clinical detection system. It can improve and enhance the accuracy and comparability of test results by conventional detection systems.
出处
《广东医学》
CAS
北大核心
2015年第23期3631-3633,共3页
Guangdong Medical Journal
基金
国家科技重大专项基金资助项目(编号:2012ZX09303009-003)
广东省科技计划项目(编号:2012KT1428)
关键词
总胆固醇
三酰甘油
参考系统
校准
一致性
total cholesterol
triglyceride
reference system
calibration
consistency
