采供血机构ALT项目性能评价及质控规则选择的研究  

Study on performance evaluation and control rules selection for ALT in blood banks

作　　者：章晓燕[1,2] 王薇[1] 赵海建[1] 王治国[1,2] 

机构地区：[1]北京医院国家老年医学中心卫生部临床检验中心北京市临床检验工程技术研究中心,北京100730 [2]北京协和医学院研究生院,北京100730

出　　处：《中国输血杂志》2016年第12期1373-1376,共4页Chinese Journal of Blood Transfusion

基　　金：北京市自然科学基金(7143182)

摘　　要：目的利用西格玛性能验证图评估采供血机构实验室丙氨酸氨基转移酶(ALT)项目性能,并帮助选择适当的质控规则和每批质控测定值数量。方法随机选择10家既参加了全国采供血机构ALT检验室间质量评价计划,又上报了ALT检验室内质量控制数据的采供血机构实验室。用国家标准GB/T 20470-2006和卫生行业标准WS/T 403-2012中ALT项目的允许总误差(20%、16%)作为质量规范,计算实验室的西格玛(σ)值并绘制西格玛性能验证图。根据西格玛性能验证图上实验室所处区域,为各实验室选择适当的ALT质控规则、每批质控测定值个数(N)和批数(R)。结果采用国家标准评价ALT性能时,10家实验室中有4家实验室的σ≥6,可选择使用13s规则,N=2,R=1;有2家实验室处于5≤σ<6,采用13s/22s规则,N=2,R=1;有2家实验室4≤σ<5,可采用13s/22s/R4s/41S规则,N=4,R=1或N=2,R=2;有2家实验室σ<4,选择13S/22S/R4S/41S/规则,N=4,R=2或N=2,R=4。采用卫生行业标准时,10家实验室中只有2家实验室σ≥6;1家实验室5≤σ<6;2家实验室4≤σ<5;有一半实验室(5家)σ<4,可选择对应的质控规则和测定值数量。结论西格玛性能验证图能直观地显示不同实验室ALT项目的性能,对《血站技术操作规程》中ALT质控方法进行补充和改进。Objective To evaluate the pertbrmance of ALT in blood banks and select appropriate control rules and numbers of measurements using sigma verification of performance. Methods Ten blood banks laboratories which participated in the transfusion medicine external quality assessment nationwide and internal quality control data reporting were chosen in this research. The total allowable errors （TEa） in national standard GB/T 20470-2006 and in health industry standard WS/ T 403-2012 were adopted as the quality specification. Sigma verification of performance were drawn using a professional soft- ware and appropriate control rules, N and R were chosen based on the zone. Results When using the total allowable error in national standard, four laboratories with σ≥〉6, 13s, N=2, R= 1 was selected. Two laboratories with 5≤r〈6, 13s/22s, N= 2, R = 1 was chosen. Two laboratories with 4≤σ〈5, 13s/22s/R4s/41s, N= 4, R = 1 or N= 2, R = 2 was chosen. Two laborato- lies were with σ4, 13s/22s/R4s/41s/8x, N=4, R=2 or N=2, R=4 may be proper. When using the TEa in health industry standard, only two laboratories had σ ≥6; one laboratory had 5 ≤ σ〈6; two laboratories had 4 ≤σ〈5; five laboratories had σ 〈4. Conclusion Sigma verification of performance can illustrate the testing performance of various laboratories and help to improve the quality control in blood banks.

关 键 词：西格玛性能验证图 丙氨酸氨基转移酶 变异系数 偏倚 

分 类 号：R457.1[医药卫生—治疗学] R446.6[医药卫生—临床医学]