胶体金法检测全血铁蛋白的性能评价及其在儿童缺铁性贫血中的临床应用

Evaluation of performance of colloidal gold method on detecting blood ferritin and the value of blood ferritin in iron deficiency anemia in children

目的评价国产胶体金法检测全血铁蛋白的分析性能,探讨其在儿童缺铁性贫血中的临床应用价值。方法通过与免疫化学发光方法比较,根据EP文件从精密度、线性范围及抗干扰能力、可比性等方面评价胶体金法测定全血铁蛋白的分析性能;随机抽取重庆医科大学附属儿童医院50例缺铁性贫血患儿及重庆市妇幼保健院健康体检儿童50例,分别测定两组全血铁蛋白,分析其诊断效率。结果胶体金法测定全血铁蛋白批间精密度分别为7.2%和9.6%,线性为0~100ng/mL,溶血、黄疸、脂血无干扰,与雅培i2000SR血清铁蛋白检测结果比对差异无统计学意义（P〉0.05）;与对照组相比,缺铁性贫血组全血铁蛋白明显降低。以20ng/mL作为诊断临界点,其灵敏度为94%,特异度为100%,诊断效率为97%。结论胶体金法分析性能良好,作为即时检测项目能满足临床,具有较高诊断效率,对儿童是否缺铁可作提示性诊断。

Objective To analyze the performance of the colloidal gold method on detecting blood ferritin and the value of blood ferritin in iron deficiency anemia children.Methods By comparing with the chemiluminescence immunoassay method,the sensitivity,the liner,comparision and the distraction-analysis of blood ferritin were estimated following the EP file.A total of 50 children from Children′s Hospital of Chongqing Medical University diagnosed with iron deficiency anemia were enrolled randomly into this observational study.Other 50 abnormal children from Chongqing Health Center of Women and Children were selected into the control group.The blood ferritin was detected in the two groups.Efficiency of diagnose was analyzed.Results Between-run assays were 7.2% and 9.6%,the linear range was 0-100ng/mL.Hemoglobin,serum bilirubin,triglyceride had no interference in blood ferritin detection.Compared with the serum ferritin of Architect i2000 SR,there was no significant difference（P〉0.05）.With the control group,the blood ferritin was significantly decreased.If 20ng/mL was used as the cut-off value,the sensitivity was 94%,the specificity was 100%,the efficiency of diagnose was 97%.Conclusion As a POCT detection project,analysis capability of the blood ferritin assayed by colloidal gold method could meet the requirements of clinical test.With good efficiency of diagnose,the method could prompt iron deficiency in children.