国产试剂在罗氏MODULAR P-800生化分析仪上的应用评价

目的评价国产试剂在罗氏MODULARP-800全自动生化分析仪（简称P-800）上应用的可行性。方法在P-800上同时使用国产试剂[丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、γ-谷氨酰基转移酶（GGT）、碱性磷酸酶（ALP）、三酰甘油（TG）、总胆固醇（TC）试剂由上海荣盛生物技术有限公司提供;总蛋白（TP）、白蛋白（Alb）、尿素（Urea）试剂由上海复星长征医学科学有限公司提供]和罗氏原装配套试剂。2种试剂的方法原理、分析类型、试剂组分及试剂剂型均相同。以罗氏原装试剂测定}昆合血清作为量值传递载体,用其校准国产试剂后对cafs校准品赋值,并以赋值后的cafs校准品、国产试剂组成测定系统。对国产试剂进行精密度评价、线性测定、偏差评估以及与罗氏原装配套试剂进行相关性分析,并对2种试剂进行抗干扰能力比较。结果国产试剂无论检测低值还是高值血清其结果批内、批间变异系数（CV）均〈5％。与罗氏原装配套试剂同时检测40份临床样本,二者所测结果基本一致（P〉0．05）,相关系数（r）均〉0．975。国产试剂与罗氏原装配套试剂的比对实验结果在医学决定水平处的偏倚均低于允许误差。2种试剂的抗干扰能力无明显差异,r均〉0．975（P〉0．05）。结论国产试剂与罗氏原装配套试剂相比相关性好、偏差小、精密度较高、线性较宽,对脂浊和黄疸样本有较好的抗干扰能力;其检验结果具有溯源性和可比性,可以替代罗氏原装配套试剂。

Evaluation of the application of homemade reagents on Roche MODULAR P-800 analyzer

Objective To evaluate the feasibility of homemade reagents on Roche MODULAR P-800 automatic biochemical analyzer (P-800). Methods The homemade reagents [made in China,the regents of alanine aminotransferase (ALT),aspartate aminotransferase (AST),γ-glutamyltransferase(GGT),alkaline phosphatase(ALP),triglyeride(TG)and total cholesterol(TG) form Shanghai Rongsheng Biotechnology Co.Ltd;the reagents of total protein(TP),albumin(Alb)and urea from Shanghai Fuson Long March Medical Science Co.Ltd] and Roche original reagents were applied on P-800. Technology principle,analysis type,component and dosage form of regent of two regents was identical.The fresh mixed serum was determined by Roche reagent, and used as temporary calibrator. The homemade reagent was calibrated by the temporary calibrator. The value of cafs calibrator was available from the calibrated homemade reagent and the cafs calibrator composed determination system with calibrated homemade reagent. The precision, linearity and bias of homemade reagent were determined. The correlation analysis of two reagents was evaluated. The interference tests of two reagents were done. Results No matter how to test the low or high level samples, the intra-assay and inter-assay coefficient of variation(CV)of homemade reagent were<5%. 40 clinical samples were detemined by two reagents. The results were similar (P>0.05) and the correlation coefficient (r) was>0.975. The bias at medical decision level was lower than permissible error range. Two regents′ antiinterference abilities had no significant difference(r>0.975, P>0.05). Conclusions Compared with Roche original reagent, homemade reagent has good correlation, little bias, high precision and wide linearity. Homemade reagents have good antiinterference ability for lipemia and icterus samples. The results can be compared and are traceable. Homemade reagent can be alternative to Roche original reagent.