三种肌酐检测方法的评价及肾小球滤过率估算

目的建立一个可行的、使用非配套肌酐（Cr）试剂的检测系统，并评估其在肾小球滤过率估算（eGFR）中的实际意义。方法以原装配套碱性苦味酸法（方法1）Cr检测为标准，对非配套Cr试剂2种方法氧化酶法（方法2）和碱性苦味酸法（方法3）]在精密度、线性、干扰情况、参考区间和方法比对等方面进行评价，并比较3种方法用于eGFR一致性。结果非配套氧化酶法Cr检测试剂在精密度（CV1．3％～2．35％）、线性（3208μmol／L）、抗干扰（胆红素500μmol／L、脂肪3．5g／L、溶血17g／L以下不干扰）检测3方面综合评估优于配套碱性苦味酸法Cr检测试剂，但在参考区间和检测结果方面差异均有统计学意义（均P〈0.01）。非配套碱性苦昧酸法Cr检测精密度低值质控批间CV=41，〉1／2CLIA＇88的CV，检测范围和抗干扰能力均较差。以配套碱性苦味酸法（检测范围30～300μmol／L）为基准，其他2种非配套Cr试剂测定结果分别计算eGFR，差异均有统计学意义（P〈0.05）；而经本研究Cr检测公式校准后，2种用非配套Cr试剂测定的eGFR结果与配套碱性苦味酸法比较差异均无统计学意义（均P〉0．05）。结论使用非配套试剂，应首先对各检测方法进行检测性能评估，并与配套试剂系统进行比较；然后根据适合临床的检验范围，用于肾小球滤过率的估算。

Assessment of three methods for detection of creatinine and in estimation of glomerular filtration rate

Objective To establish a creatinine assay system with non-matching reagents, and to evaluate its application in assessment of glomerular filtration rates. Methods The commercial creatinine test kit was used as standard, the results of which were compared with those derived from other two non-marching reagents methods： oxidase method （method 2） and alkaline picric acid method （method 3）. The precision, linearity, anti-interferences and reference interval of 3 methods were compared in estimating GFR consistency. Results The precision （CV1.3%-2.35% ）, linearity （3 208μ mol/L） and anti-interference ability （no interference under the following concentration： bilirubin 500 μ mol/L, fat 3.5 g/L, hemolytic 17 g/L） of method 2 were superior to those of method 1, but there were significant differences in the reference interval （P 〈 0.01） and the test results （P 〈0.01） between two methods. The precision at low-value （interassay CV = 4.1）, the scope of testing and anti-interference ability of method 3 were poor. When method 1 was used as the benchmark （detection range of 30 - 300 IJ mol/L） to estimate GFR, there were significant differences among three methods （P 〈 0.01）; however, when the results derived from method 2 and 3 were calibrated with those from method 1 there were no significant differences （P〉 0.05）. Conclusion Before the creatinine kits with non-matching reagents are used to estimate glomerular filtration rate, they should be compared and calibrated with standard kits with the complete reagent system.