摘要
目的对罗氏ModularDDP全自动生化分析仪血清铁(SI)的检测进行方法学评价,并建立本实验室的参考区间。方法用FerroZine法检测SI,依据美国临床实验室标准化委员会EP文件要求验证精密度、准确度、线性范围、检测限(检出限)、抗干扰试验,并取240例健康体检者样本,建立本实验室的参考区间。结果经检测显示:本实验室SI检测的精密度小于2%,准确度97.93%～103.48%,线性范围0.95～184.40μmol/L,最低检出限为0.28μmol/L;血红蛋白浓度小于2.88g/L,三酰甘油浓度小于72.45mmol/L时无明显干扰;本实验室血清铁参考区间为男:7.14～35.66μmol/L;女:5.94～27.40μmol/L。结论本系统检测性能符合美国病理学家协会(CAP)要求,参考区间与《全国临床检验操作规程》(第3版)血清铁测定的参考区间有明显差异,说明该参考区间不可直接引用,也说明了进行方法学评价的重要性。
Objective To evaluate the serum iron（SI） detection method in the Roche ModularDDP automatic biochemical analy zer,and establish the laboratory reference range. Methods We collected 240 samples of healthy people,detected SI with FerroZine spectrophotometry and established the laboratory reference interval. According to American Society for Clinical Laboratory Stand ards Committee EP documents, the detection of SI was evaluated with the precision, accuracy, linearity, detection limit （detection limit） and interference. Results The accuracy of SI was below 2 %, the accuracy was between 97.93 and 103.48 %, with mini mum detection limit as 0.28 μmol/L,the linearity was from 0.95 μmol/L to 184.40 μmol/L. Hemoglobin（〈l. 3 g/L） and Triglyc eride（〈50 mmol/L） in the sample had no significant interference in the assay. Our laboratory serum ferritin reference interval for men was 7.14-35.66μmol/L,and for women was 5.9427.40 μmol/L. Conclusion The detection performance of the system is in line with the College of American Pathologists（CAP）, while the reference interval has significant difference with the ＂Clinical La boratory Procedures（Third edition） reference intervals for serum iron determination. The results displays that the reference ranges can not be directly quoted,and suggests the importance of a methodological evaluation.
出处
《国际检验医学杂志》
CAS
2012年第23期2875-2876,2878,共3页
International Journal of Laboratory Medicine
