血站实验室ALT检测性能验证方法的探讨  

Study on the performance of ALT detection as a verification method in blood station laboratory

作　　者：高景波 王雪妹 韦旭 刘艳春 王芳[1] 

机构地区：[1]辽宁省血液中心,辽宁沈阳110044

出　　处：《中国输血杂志》2015年第9期1094-1097,共4页Chinese Journal of Blood Transfusion

摘　　要：目的对自建检测系统进行ALT生化项目的性能验证。方法根据ISO15189和中华人民共和国卫生行业标准(WS/T)及美国临床和实验室标准研究院(CLSI)相关文件,进行精密度、正确度、线性范围、生物参考区间、分析灵敏度和干扰试验的验证。结果批内精密度在0.54%-3.51%,批间精密度在0.72%-4.24%,正确度偏倚在-5.37%-3.03%,检测结果均符合本实验室要求;线性范围为(9.1-929.6)U/L;引用的生物参考区间符合本实验室服务的人群;分析灵敏度验证其吸光度变化率为0.020,与厂家声称的范围相符;干扰试验显示不同浓度VC、CB、UB、HB对ALT检测均无明显干扰,高浓度乳糜微粒对ALT检测有明显负干扰。结论自建检测系统性能验证结果能满足相应标准的要求,同时相比配套检测系统又具有价格优势,可以考虑推广使用。高浓度乳糜标本的血液检测应引起重视,可采取必要的屏蔽措施。Objective To test the performance of a self-established detection system used in ALT biochemistry project. Methods According to the ISO15189, the People＇s Republic of China health industry standard （WS/T） and the related documents from Chnical and Laboratory Standards Institute （CLSI）, the precision, accuracy, linearity range, biological reference interval, sensitivity of analysis and interference test were tested. Results The degree of intra-batch precision was 0. 54% - 3.51% and the degree of inter-batch precision was 0. 72% - 4. 24%. The accuracy of bias ranged from - 5.37% to 3.03%. The results from the detection conformed to the requirements of the laboratory. The linear range was （9. 1 - 929. 6） U/L. The biological reference range corresponded to the target population identified by this laboratory. The results of sensitivity analysis showed that the variable rate of absorbance was 0. 020, which was in accordance with the statement of the manufacturers. Different concentrations of VC, CB, UB and HB had no significant effects on the detection performance of ALT, while high concentration of chylomicrons brought a negative effect. Conclusion Compared with other detection systems, this self-made detection system was cost efficient. In addition, the performance of this system meets the relevant standard requirements. This system is worth wide application in laboratories. Also, more attention should be paid to the blood test of high concentration of chylomicron samples and necessary measures should be taken in prevention efforts.

关 键 词：性能验证 精密度 准确度 线性范围 干扰试验 

分 类 号：R446.6[医药卫生—诊断学]