B品牌全自动生化分析仪检测血清脂肪酶和胆碱酯酶的性能验证

Verification of the performance of brand B automatic biochemistry analyzer for the detection of serum triacylglycerol lipase and cholinesterase

目的对脂肪酶(LPS)和胆碱酯酶(CHE)试剂盒在B品牌全自动生化分析仪上的检测性能进行分析评价,确保检测结果的准确性。方法参照CNAS和WS/T等相关系列文件设计性能验证方案,对B品牌测定脂肪酶和胆碱酯酶的精密度、正确度、线性区间、可报告范围和生物参考区间进行验证及评价。结果LPS的低、高水平质控品的批内不精密度变异系数(CVr)和总不精密度的变异系数(CV1)值分别为:4.32%、4.10%,1.64%、1.73%;CHE的低、高水平质控品的CVr和CV1分别为:1.31%、1.27%,0.98%、0.88%;检测实验室能力验证(PT)样本的LPS和CHE水平验证正确度,偏倚均符合要求;LPS线性区间在4.63~512.60 U/L内良好(Y=0.9945 X+0.4739,r 2=0.9997)、最大可报告范围扩展至1537.80 U/L,CHE线性区间在1.27~14.75 kU/L内良好(Y=1.004 X-0.2436,r 2=0.9978)、最大可报告范围扩展至29.50 kU/L;试剂说明书提供的生物参考区间均验证通过(符合率均≥95%)。结论B品牌全自动生化分析仪检测LPS和CHE的精密度、正确度、线性区间、临床可报告范围和参考区间性能验证良好,能够规范检测、确保检测质量,满足临床需求。

Objective To analyze and evaluate the detection performance of lipase(LPS)and cholinesterase(CHE)test kits on the B brand fully automatic biochemical analyzer,in order to ensure the accuracy of the detection results.Methods The performance verification scheme was designed according to CNAS and WS/T documents.The precision,trueness,linear interval,clinical reportable range,and biological reference interval of LPS and CHE were tested and evaluated by Backman AU5800 automatic biochemical analyzer.Results The Intra-batch unrefined density(CVr)and the total unrefined density(CV1)of low and high quality controls for LPS were 4.32%,4.10%,1.64%,1.73%,respectively;The CVr and CV1 of low and high quality controls for CHE were 1.31%,1.27%,0.98%,0.88%,respectively.To verify the trueness,the levels of LPS and CHE in Proficiency Testing(PT)samples were detected,and the biases can meet the requirements.The linear interval of LPS was good within 4.63-512.60 U/L(Y=0.9945 X+0.4739,r 2=0.9997),and the clinical reportable range can be extended to 1537.80 U/L.The linear interval of CHE was good within 1.27-14.75 kU/L(Y=1.004 X-0.2436,r 2=0.9978),and the clinical reportable range can be extended to 29.50 kU/L.The biological reference intervals of LPS and CHE provided by the reagent manuals were verified(coincidence rate≥95%).Conclusion The precision,accuracy,linear interval,clinical reportable range,and reference interval performance of the B brand fully automatic biochemical analyzer for detecting LPS and CHE have been well validated,which can standardize the detection,ensure the quality of the detection,and meet clinical needs.