全自动生化分析仪测定D-二聚体的分析性能评价

Performance Evaluation of Automatic Biochemical Analyzer in D-Dimer Test

目的对在日立7170全自动生化分析仪上用免疫透射比浊法检测D-二聚体的性能进行评价.方法对全自动生化分析仪测定血浆D-二聚体的精密度、正确度、分析灵敏度、分析测量范围、分析干扰和生物参考区间6项分析性能进行验证和评价.结果 D-二聚体测定在3个不同浓度水平的批内不精密度和天间不精密度都小于厂家规定的不精密度要求;4个浓度校准品检测结果与靶值的相对偏差均<15%;功能灵敏度为0.46μg/mL,分析测量范围为0.30～42.95μg/mL,略低于厂家给定的范围;生物参考区间验证结果 <1μg/mL,在试剂说明书的范围之内.不同浓度游离胆红素、结合胆红素、乳糜物、血红蛋白对D-二聚体检测不产生影响.结论日立全自动生化分析仪测定D-二聚体的分析性能与厂家声明基本一致,符合临床要求,可以应用于临床.

Objective To evaluate the performance feature of Hitachi 7170 automatic biochemical analyzer in D-dimer test. Methods According to the evaluation protocols documents and peninent litemture, and by combining our actual work, the precision, accuracy, analyticai sensitivity, analytical measurement range, and the biological reference range of D-dimer were verified and evaluated. Results The inexactitude within-batch and day was superior to the standard of manufacturer. The related biases between results measured for calibrator at four levels and target valule was less 15% .Functional sensitivity was 0.46 μg/mL. Analytical measurement range was 0.30-42.95 μg/mL, that lower t than the manufacturer＇s claim slightly.The biological reference range was〈 1 μg/mL , within manufacturer＇s claimed. Different concentrations of free bilirubin, direct bilirubin, chylomierons, hemoglobin will not influence D-Dimer detection. Conclusion The main analytical performances of D-Dimer test with automatic biochemical analyzer are consistent with the claim defined by manufacturer, and could be satisfied in the clinical determination.