CAJ | 학술논문

目的：探讨建立一种改良酶法肌酐（Cr）测定试剂，并考察其与进口Cr测定试剂（日本东洋纺公司酶法Cr试剂）对血清测定的可比性及偏倚。方法采用酶法测定 Cr 反应前后吸光度的变化，探讨试剂各成分和浓度对检测性能的影响，并在同一台全自动生化分析仪上同时测定两种试剂的空白吸光度（A 值）、分析灵敏度，对自主研发试剂的精密度、线性范围及方法学指标进行评价。结果自主研发试剂的空白 A 值为0．009，分析灵敏度的 A 值变化率为0．13，优于进口试剂。自主研发试剂高、低值血清测定变异系数分别为1．5％和1．1％；线性范围为0～2850μmol／L；方法学比对回归方程为Y ＝0．98X ＋1．15，r＝0．999；估计偏倚低于允许误差。以相对偏差不小于10％作为有明显干扰的评判指标，结果显示35 mmol／L 肌酸、3．42 mmol／L 胆红素、0．03 g／L 维生素 C、5 g／L 血红蛋白、1450浊度乳糜对高、低值浓度标本检测结果均无干扰。结论自主研发的 Cr 测定试剂性能良好，与进口试剂之间具有良好的相关性，符合临床应用基本要求。
목적：탐토건립일충개량매법기항（Cr）측정시제，병고찰기여진구Cr측정시제（일본동양방공사매법Cr시제）대혈청측정적가비성급편의。방법채용매법측정 Cr 반응전후흡광도적변화，탐토시제각성분화농도대검측성능적영향，병재동일태전자동생화분석의상동시측정량충시제적공백흡광도（A 치）、분석령민도，대자주연발시제적정밀도、선성범위급방법학지표진행평개。결과자주연발시제적공백 A 치위0．009，분석령민도적 A 치변화솔위0．13，우우진구시제。자주연발시제고、저치혈청측정변이계수분별위1．5％화1．1％；선성범위위0～2850μmol／L；방법학비대회귀방정위Y ＝0．98X ＋1．15，r＝0．999；고계편의저우윤허오차。이상대편차불소우10％작위유명현간우적평판지표，결과현시35 mmol／L 기산、3．42 mmol／L 담홍소、0．03 g／L 유생소 C、5 g／L 혈홍단백、1450탁도유미대고、저치농도표본검측결과균무간우。결론자주연발적 Cr 측정시제성능량호，여진구시제지간구유량호적상관성，부합림상응용기본요구。
Objective To develop improved enzymatic creatinine(Cr)assay reagents (self-R&D),and to investigate their appli-cation on serum detection by comparing with imported commercial Cr reagents(enzymatic Cr reagents from Toyobo)Methods En-zymatic method was used to evaluate the effect of every component and different concentrations of reagents on Cr assay by detecting the alteration of absorbance of Cr before or after the reaction.Meanwhile,the blank absorbance and analysis sensitivity of self-R&D and imported reagents,the technical indicators of precision,linearity,as well as method comparison of self-R&D reagents,were de-tected on the same automatic biochemical analyzer.Results The blank absorbance of self-R&D reagents was 0.009,and the detec-tion sensitivity was 0.13,better than that of imported Cr reagents.The coefficient of variation (CV)of high and low values of ser-um of self-R&D reagents were 1.5%,and 1.1%,respectively.The linear range was 0-2 850 μmol/L and the method comparison result was Y =0.98X +1.15 (r =0.999).The expected bias was less than the allowable error region.Using relative deviation≥10% as an index to evaluate the existence of significant interference,it shows that 35 mmol/L of creatine,3.42 mmol/L of biliru-bin,0.03 g/L of vitamin C,5 g/L of hemoglobin and 1450 FTU chyle in both low and high concentration serum samples did not interfere with the test result.Conclusion The quality of self-R&D reagents was good,and there was a good relativity between self-R&D reagents and imported Cr reagents with excellent quality.This indicates the self-R&D reagents could satisfy the application requirements of the clinics.