全自动生化分析仪测定血清高密度脂蛋白胆固醇分析性能评价

Performance evaluation of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol

目的对在日立7600全自动生化分析仪上用均相测定法检测高密度脂蛋白胆固醇(HDL-C)的分析性能进行评价。方法参考国内外有关性能评价的文件和报道,结合临床工作实际,对全自动生化分析仪测定血清HDL-C的精密度、正确度、分析测量范围、分析干扰和生物参考区间5项分析性能进行验证和评价。结果HDL-C测定在3个不同浓度水平的批内和天间不精密度都小于厂家规定的不精密度要求;5个不同批号的室间质控品检测结果与靶值的相对偏倚均小于允许偏倚;分析测量范围为0～5.21mmol/L,略宽于厂家给定的范围;生物参考区间验证结果均在设定的范围之内;不同浓度游离胆红素、结合胆红素、乳糜物、血红蛋白对HDL-C检测不产生影响。结论日立全自动生化分析仪测定HDL-C的分析性能与厂家声明基本一致,符合临床的要求,可以应用于临床。

Objective To evaluate the performance feature of automatic biochemical analyzer on detection of serum high density lipoprotein cholesterol （HDL-C）. Methods Referring to the evaluation protocol documents and literature and combining our actual work, the precision, accuracy, analytical measurement range, and biotic interval of HDL-C were validated. Results The within-run and day precision were all consistent with the claim of manufac- turer. The biases of mean and target value that detected in five quality control specimens were in the range of permis- sion. Analytical measurement range was 0-5.21 mmol/L, that wider than the manufacture＇s claim slightly. The bi- ological reference range was within the setting range. Different concentrations of free bilirubin, direct bilirubin, chy lomicrons, and hemoglobin had no influence on HDL-C detection. Conclusion The main analytical performances of serum total bile acid by automatic biochemical analyzer were consistent with the claim defined by manufacturer, and could be satisfied with the clinical detection.