Olympus 2700全自动生化分析仪使用国产试剂的性能评价

Evaluation of homemade reagents on Olympus 2700 automated biochemistry analyzer

目的评价Olympus 2700(简称AU2700)全自动生化分析仪使用国产试剂的性能,判断其分析性能是否满足临床要求。方法根据美国临床实验室标准化研究所(CLSI)制定的评价标准,使用国产生化试剂对AU2700的精密度、线性范围、抗干扰性、回收率和携带污染率进行评价试验。结果通过对8个代表项目葡萄糖(GLU)、丙氨酸氨基转移酶(ALT)、碱性磷酸酶(ALP)、总蛋白(TP)、肌酸激酶(CK)、肌酐(Cr)、甘油三酯(TG)、总胆固醇(TC)的检测,精密度试验批内、批间变异系数(CV)均<5%;线性试验相关系数分别是:0.99、0.97、0.98、0.99、0.97、0.99、0.96、0.97;抗干扰试验:胆红素<300μmol/L对8个检测项目均无影响,血红蛋白<2 g/L对Cr、TG、TC和GLU测定结果的干扰程度<10%,血红蛋白<5 g/L对TP、CK、ALT测定结果的干扰程度<10%,血红蛋白<10 g/L对ALP测定结果的干扰程度<10%;携带污染率分别是0.04%、0.52%、0.39%、0.78%、0.64%、0.48%、0.55%、0.68%;回收率分别是99.9%、100.1%、98.3%、100.5%、99.2%、100.5%、98.9%、99.7%。结论 AU2700全自动化分析仪使用国产试剂时精密度高、线性好、携带污染率低、对轻微溶血和黄疸标本有较好的抗干扰性,各项指标均符合临床实验室要求,也达到国家规定的相关标准。

Objective To evaluate the efficiency and clinical satisfaction of homemade reagents on Olympus 2700 Automated Biochemistry analyzer.Methods With the evaluating standard produced by Clinical and Laboratory Standards Institute（CLSI）,We evaluated the precision,linearity,interference,rate of recovery and cross contamination with homemade reagents in AU2700.Results 8 items were tested including glucose（GLU）,alanine aminotransterase（ALT）,creatine kinase（CK）,alkaline phosphatase（ALP）,total Protein（TP）,Creatinine（Cr）,triglyeerides（TG） and total cholesterol（TC）.All total coeficient of variation（CV） of precision tests were less than 5%.The correlation coefficients of linearity tests were 0.99,0.97,0.98,0.99,0.97,0.99,0.96 and0.97.The interference was no significant to all items when bilirubin 300 μmol/L.The rate of interference was 10% to Cr,TG,TC and GLU,when haemoglobin 2 g/L,10% to TP,CK,ALT,when haemoglobin 5 g/L and10% to ALP,when haemoglobin10 g/L.The rate of cross contamination was 0.04%,0.52%,0.39%,0.78%,0.64%,0.48%,0.55% and 0.68%.The rate of recovery was 99.9%,100.1%,98.3%,100.5%,99.2%,100.5%,98.9%and 99.7%.Conclusions With homemade reagent,Olympus 2700 automated biochemistry analyzer showed high precision,good linearity,low rate of cross contamination,and have good anti-interference ability for mild haemolysis and jaundice samples.