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透射比浊法铁蛋白试剂盒的性能评价
引用本文:俞俊文,贺嘉蕾,范华.透射比浊法铁蛋白试剂盒的性能评价[J].中国医学检验杂志,2011(3):117-118.
作者姓名:俞俊文  贺嘉蕾  范华
作者单位:[1]叶城县人民医院检验科,新疆叶城844900 [2]中国人民解放军四一一医院,上海200081 [3]宁波普瑞柏生物技术有限公司,浙江宁波315033
摘    要:目的]了解免疫透射比浊法铁蛋白试剂盒的性能指标。方法]测定该试剂盒的不精密度、线性范围、灵敏度、准确度。结果]免疫透射比浊法铁蛋白试剂盒的批内精密度1.0%~9.0%,批问精密度7.2%~11.8%,线性范围14~300斗∥L、灵敏度(检测低限)为14¨g/I.、准确度为105.9%。结论]免疫透射比浊法检测铁蛋白在不精密度、线性范围、灵敏度、准确度方面均能满足临床需要,并且还具有快速、简便及成本低廉的特点,适合临床使用。

关 键 词:免疫透射比浊法  铁蛋白  性能评价

Performance evaluation on an immunoturbidimetric ferritin kit
Yu Junwen,He Jialei,Fan Hua.Performance evaluation on an immunoturbidimetric ferritin kit[J].Chinese Journal of Medical Laboratory Technology,2011(3):117-118.
Authors:Yu Junwen  He Jialei  Fan Hua
Affiliation:. Laboratory Department, Yecheng County People's Hospital, Yecheng 844900, China
Abstract: Objective] To evaluate the performance of an immunoturbidimetric ferritin kit in clinical use. Methods ] The imprecision, linearity range, lower limit of detection and accuracy were determined on the automatic chemistry analyzer Hitachi 7170. Results] The within - run imprecision was 1.0% -9.0 while the between - run imprecision 7.2% - 11.8%. The linearity range was 14 - 300 μg/L. The lower limit of detection was 14 μg/L and the accuracy 105.9%. Conclusionl The ferritin kit shows good performance in clinical use.
Keywords:lmmunoturbidimetric assay  Ferritin  Performance evaluation
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