迈瑞BS-800生化分析仪血清指数参考区间的确立及性能评价

目的 制定迈瑞BS-800全自动生化分析仪血清指数的参考区间及评估血清指数的可靠性.方法 取正常健康体检标本985例,采用迈瑞BS-800全自动生化分析仪测定脂血指数（L）、溶血指数（H）、黄疸指数（Ⅰ）,制定血清指数的参考区间及线性范围.参考CLSI方法学评价方案,对血清指数的线性、精密度、准确度进行实验和统计分析.用能力对比（PT）实验评价方法的正确度.结果 迈瑞BS-800全自动生化分析仪L,H,I的参考区间分别为＜9.29,＜17.37,＜1.67;L,H,I的线性分别为1～230,2.17～1 200,0.099～40;三项指数批内、批间、天间及总不精密度均小于6％;L与FTU浊度、H与Hb（mg/dl）、Ⅰ与TBIL（mg/dl）具有很好的相关性（r全部＞0.975）,测量结果差异无统计学意义（P＞0.05,H经校正后）;能力对比（PT）试验结果显示Ⅰ测定TBIL准确度良好.结论 迈瑞B＆800全自动生化分析仪的血清指数线性宽,重复性好,通过制定参考区间,对血清混浊、溶血、黄疸程度提供了一个客观的参考.

Establish Reference Interval of Serum Indexes and Its Performance Evaluation in Mindray BS-800 Automatic Biochemical Analyzer

Objective To establish reference intervals of serum indexes in Mindray BS-800 automatic biochemical analyzer and evaluate the reliability of serum indexes.Methods lipoidemia index （L）,hemolysis index （H） and icterus index （Ⅰ） were determined after analysis of 985 healthy sera samples collected during physical examination by using Mindray BS-800 automatic biochemical analyzer to establish reference interval of serum indexes.Based on CLSI methodological evaluation protocol,the linearity,precision and accuracy were tested and statistically analyzed and the accuracy of the evaluation method was evaluated with Proficiency Testing （PT）.Results The reference interval and linearity of L,H and I were ＜9.29,＜17.37 and ＜1.67,and 1～ 230,2.17～ 1 200,0.099 ～40,respectively; the intra-assay,inter-assay,between day and total imprecision were all less than 6 ％ ;L and FTU turbidity,H and Hb（mg/dl）,I and TBIL（mg/dl） showed strong correlation （r＞0.975）,with no statistically significant difference to the determining results;PT test indicated good accuracy of TBIL determination by Ⅰ.Conclusion Serum indexes determined by Mindray BS-800 automatic biochemical analyzer have a wide linear range and good repeatability,which provides objective reference values for serum turbidity,hemolysis and jaundice severity.