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目的评价国际参考实验室能力验证样品(RELA-A/B)的均匀性是否满足参考实验室比对的要求。方法参照CNASGL03《能力验证样品均匀性和稳定性评价指南》,用Roche Modular P800生化分析仪测量2014至2016年连续3年RELA-A/B的14个项目,即丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、L-γ-谷氨酰基转移酶(GGT)、肌酸激酶(CK)、乳酸脱氢酶(LDH)、总蛋白(TP)、总胆红素(T-Bil)、尿素(Urea)、肌酐(Cr)、尿酸(UA)、葡萄糖(Glu)、三酰甘油(TG)、总胆固醇(TC)。计算测量结果均值()、标准差(s)和变异系数(CV),用单因素方差分析和SS≤0.3σ准则分析评价其瓶间差异。结果 RELA 2014A和2014B样品AST测量结果 CV>2.0%。除RELA 2016B样品CK测量结果 CV<2.0%外,其他样品CK测量结果 CV均>2%。单因素方差分析结果显示,所有样品中CK测量结果 F均>临界值4.39,差异有统计学意义(P<0.05);2015B样品ALT和T-Bil,2014A样品Cr测量结果 F均>临界值4.39,差异有统计学意义(P<0.05);其他测量结果 F均<临界值4.39,差异无统计学意义(P>0.05)。S_S≤0.3σ准则分析结果显示,所有样品CK测量结果 S_S>0.3σ,CK测量结果存在瓶间差异;其他项目测量结果 S_S均≤0.3σ,其他项目测量结果无瓶间差异。结论国际参考实验室能力验证样品CK项目存在瓶间差异,值得注意;其他项目均匀性能满足参考实验室能力验证要求。
Objective To evaluate whether the uniformity of RELA-A / B samples meets the requirements of reference laboratories. Methods According to CNASGL03, “Guidelines for the Evaluation of Homogeneity and Stability of Capability Validated Samples”, 14 projects of RELA-A / B for 3 consecutive years from 2014 to 2016 were measured with a Roche Modular P800 biochemical analyzer, namely, alanine aminotransferase (ALT ), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), L-γ-glutamyltransferase (GGT), creatine kinase (CK), lactate dehydrogenase TP, T-Bil, Urea, Cr, UA, Glu, TG and TC. The mean (), standard deviation (s) and coefficient of variation (CV) of the measurement results were calculated. One-way ANOVA and SS≤0.3σ criteria were used to evaluate the differences between the two bottles. Results RELA 2014A and 2014B samples AST measurement CV> 2.0%. Except for CV <2.0% for RELA 2016B sample CK, the CV of other samples CK was> 2%. The results of one-way ANOVA showed that the F value of CK in all the samples was> 4.39, the difference was statistically significant (P <0.05). The Cr values of 2015B samples and 2014A samples were both> 4.39 , The difference was statistically significant (P <0.05); other measurements F 0.05). The results of S_S≤0.3σanalysis show that S_S> 0.3σ for all samples CK, and bottleneck differences for CK measurements; S_S≤3.3σ for other items, and no bottle differences for other items. Conclusion There is a bottleneck difference between the CK samples of the international reference laboratory proficiency test samples. It is noteworthy that other items have uniform properties that meet the requirements of reference laboratory proficiency testing.