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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 assess the performance of the ALT program in laboratories for collecting and supplying blood using SIGMA performance validation maps and to help select the appropriate QC rules and the number of QC tests per batch. Methods A total of 10 randomly selected participants participated in the ALT laboratory quality assessment plan of national blood collection and supply agencies and also reported the laboratory for blood sampling and blood supply of ALT laboratory quality control data. Calculate lab sigma values and plot sigma performance using the total allowable error (20%, 16%) of ALT projects in national standards GB / T 20470-2006 and health industry standard WS / T 403-2012 as a quality specification Verification chart. Based on the area where the lab is located on the Sigma Performance Validation Map, select the appropriate ALT quality control rules for each laboratory, the number of quality control tests per batch (N), and the number of batches (R). Results When using the national standard to evaluate the performance of ALT, there are 4 laboratories in 10 laboratories with σ≥6, 13s rule can be selected, N = 2 and R = 1; 2 laboratories are in 5≤σ <6, Using 13s / 22s rule, N = 2, R = 1; 2 laboratories 4≤σ <5, 13s / 22s / R4s / 41S rule, N = 4, R = 1 or N = 2, R = 2; with 2 laboratories sigma <4, 13S / 22S / R4S / 41S / rule selected, N = 4, R = 2 or N = 2, R = 4. When using the hygienic industry standard, only two laboratories in the 10 laboratories had σ ≥ 6; one laboratory 5 ≤ σ <6; two laboratories 4 ≤ σ <5; and half of the laboratories (5) σ <4 , You can choose the corresponding quality control rules and the number of measured values. Conclusion The Sigma Validation Chart can visually show the performance of ALT projects in different laboratories and supplement and improve the ALT quality control methods in the Blood Station Technical Code of Practice.