自配Dimension AR CO_2酸性释放液与进口试剂的比较

Comparison between self-made and foreign carbon dioxide release fluids in Dimension AR analyzer reagent

目的 比较自配DimensionAR全自动生化分析仪二氧化碳酸性释放液与进口试剂的质量。 方法 根据二氧化碳电极法测定TCO2 的原理 ,自配二氧化碳酸性释放液。测定自配液与进口试剂的主要理化指标、pH、电极斜率、精密度、相关性和稳定性。 结果 自配二氧化碳酸性释放液与进口原装二氧化碳酸性释放液的主要理化指标、pH、电极斜率均一致 ,该法的线性为 5～ 45mmol L ,r =0 .999,Y =1.0 0 85X +0 .2 17。精密度 :批内CV <3.19% ,总CV <5 .6 4%。自配液 (Y)与原装液 (X)相关性良好 ,r =0 .996 1,Y =1.0 0 0 2X - 0 .2 70 3。自配液使用 6个月对电极无损害。 结论 自配二氧化碳酸性释放液的准确度与精密度符合临床要求 ,提示自配液可替代进口原装液。

Objective To compare the quality of self-made and foreign carbon dioxide release fluids in Dimension AR analyzer reagent. Methods According to the principle of electrode method for detecting TCO 2, the carbon dioxide release fluid was prepared.To compare the pH,electrode slope scope,precision,correlation and stability between two fluids. Results The main biochemical items such as pH ,electrode slops scope between our developed carbon dioxide release fluid and primary carbon dioxide release fluid in Dimension AR reagent were in good accordance. The linearity was 5～45 mmol/L; r=0.999, Y=1.0085X+0.217. The precision were <3.19% for within-run CV, and <5.64% for total CV. Correlation between results obtained by self-made (Y) and foreign primary carbon dioxide release fluid (X) was Y=1.0002X - 0.2703,r=0.9961 .No damage of electrodes was observed after six months. Conclusion The accuracy of our developed carbon dioxide release fluid meets the qualifications of clinical application and it indicated that we can substitute our developed carbon dioxide release fluid for the primary carbon dioxide release fluid.