肝功能相关酶学检测指标国产诊断试剂的质量比对研究

摘要

Objective To evaluate the feasibility of application of homemade reagents measurement of liver functional correlation tests on Roche MODULAR P-800 analyzer(P-800). Methods The homemade reagents including alanine amino-transferase(ALT),aspartate aminotransf erase (AST) ,7-glutamyltransferase (GGT) and alkaline phosphatase(ALP) were from Shanghai Fuson Long March Medical Science Co. Td. Homemade reagents and Roche original reagents were applied on P-800. The precision,linearity and ability of anti-interference of homemade reagents were determined and the correlation analysis of two reagents was evaluated. Results The datas showed that intra-assay and inter-assay coefficient of variation (CV) of homemade reagents were all <5%. The linear range of homemade reagents were achieved the range that confirmed on instruction manual. There was no significant difference between homede reagents and Roche original reagents for their ability of anti-interference. 40 clinical samples were detemined by two reagents. The results were no significant difference (P>0. 05) and the correlation coefficient (r) was >0. 975. Conclusion Compared with Roche original reagent,the homemade reagents of ALT, AST, ALP and GGT had high precision,good correlation. The linearity and anti-interference ability was as same as Roche original reagent. Homemade reagent could be alternative to Roche original reagent.%目的 评价在罗氏MODULAR P-800全自动生化分析仪(简称P-800)上应用国产诊断试剂检测肝功能相关指标的可行性.方法 应用上海复星长征医学科学有限公司和罗氏原装配套试剂,在P-800上同时测定丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、谷氨酰基转移酶(GGT)和碱性磷酸酶(ALP).评价国产试剂的批内批间精密度、线性范围、抗干扰能力以及与罗氏原装配套试剂进行相关性分析.结果 精密度试验结果表明,国产试剂检测结果批内、批间变异系数(CV)均<5%;线性范围验证试验表明国产试剂基本达到说明书声称的线性范围;干扰试验表明国产试剂与原装配套试剂的抗干扰能力无明显差异;方法学比对试验结果表明,应用国产试剂和原装配套罗氏试剂同时检测40份临床样本,其检测结果基本一致(P>0.05),相关性较好(r>0.975,b在1.0±0.05之间).结论 对于该研究涉及的四项肝功能相关酶学诊断指标,应用国产试剂与罗氏原装配套试剂相比,其相关性较好、精密度较高、线性范围达到说明书规定范围,对胆红素和乳糜有较好地抗干扰能力;肝功能相关国产诊断试剂检验结果与罗氏原装配套试剂具有可比性,可替代进口试剂,实现国产化.