国产浓缩型酶法二氧化碳试剂盒的应用研究

Application Evaluation of Domestic Carbon Dioxide（CO2） Assay Kit with Concentrated Enzymatic Method

目的探讨浓缩型酶法二氧化碳（CO2）试剂盒在RocheModular生化分析仪中的检测性能。方法根据CIS1系列文件（Et15-A2，EP6-A，EP9-A2，C28-A3）和其他相关文献的实验方案，对迈克浓缩型酶法C02的精密度、线性范围、参考区间及其与Roche配套试剂进行可比性分析，结果与厂商声明的性能或者公认的质量目标进行比较。同时比较分析迈克与罗氏试剂检测参数，高中低浓度标本结果及其检测点吸光度值变化。结果精密度性能通过验证；呈一次线性，线性范围为5．8～43．8mmol／L；与罗氏原装试剂具有较好的可比性，回归方程为Y-0．9822X＋0．0208，相关系数r=0．99】6；参考区间验证结果均在该实验室给出的参考区间内；迈克和罗氏试剂的参数设置略有不同，高中低浓度标本栓刹点吸光度值差异具有统计学意义（P〈0．05），但检测结果差异无统计学意义（P〉0．05）。结论迈克浓缩型酶法C0。试剂盒在Roche Modular检测中的主要分析性能均符合盾量目标耍求，满足临床需娶．

Abstract：Objective To evaluate the analytical performance of tim domestic Maker carbon dioxide （CO2） assay using concen- trated enzymatic method by Roche Modular automatic biochemical analyzer. Methods The precision,linearity,comparability and reference interval validation were performed according to Clinical and Laboratory Standards Institute （CI.SI） documents （EP15-A2, EP6-A,EPg-A2,C28-A3） and other relevant protocols. In addition, method comparison studies were carried out against two methods （Maker and Roche）, the parameters, absorbance values at 2 detection points, test results were compared between the two methods. Results The precision performance was in line with the Manufacturer＇s claims. Linearity was proven from 5.8 to 43. 8 mmol/L. Good agreement was achieved in the comparisons between Maker and Roche COz assay （Y = 0. 982 2 X＋0. 020 8, r=0. 991 6）. The parameter settings of Maker CO2 asssy were slightly different from Roche COz as- say. Ahhough the absorbance values showed statistical difference at 2 major detection points （P〈0.05）, but there was no statistically significant difference between the test results （P〉0. 05）. Conclusion The Maker CO2 assay was shown to be precise and accurate with proven linearity,and it is very well suited for clinical use on Roche Modular chemistry analyzers.