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目的评估铁蛋白快速检测试剂盒的性能以及用于婴幼儿检测的可靠性和易用性。方法验证试剂盒的灵敏度、精密度、准确度指标,评估检测方法的可靠性,并用该试剂盒测定1 664例<5岁婴幼儿铁蛋白水平评估检测方法的易用性。结果铁蛋白快速检测试剂盒的灵敏度1.2 ng/ml,批内、批间变异系数均<8%,与定值质控品标定浓度的相对偏差<10%,与化学发光法比对的相关系数0.993,且测定结果差异无统计学意义(P>0.05)。用该法检测<5岁婴幼儿手指血铁蛋白浓度,缺铁率29.7%,随年龄增长缺铁率逐步降低。结论铁蛋白快速检测试剂盒适合用于婴幼儿铁缺乏症的筛查,是简便、易行、可靠、快捷的方法。
Objective To assess the performance of ferritin rapid test kits and the reliability and ease of use for infant testing. Methods The sensitivity, precision and accuracy of the kit were tested to evaluate the reliability of the assay. The kit was used to evaluate the ease of assessing the detection of ferritin levels in 1 664 infants <5 years of age. Results The sensitivity of the ferritin kit was 1.2 ng / ml, the coefficient of variation (CV) was <8% within batch and batch, and the relative deviation from the calibrator was <10%. The correlation coefficient with chemiluminescence 0.993, and the difference was not statistically significant (P> 0.05). The method was used to detect the concentration of finger ferritin in infants younger than 5 years. The iron deficiency rate was 29.7%. The iron deficiency rate gradually decreased with age. Conclusion The ferritin rapid test kit is suitable for the screening of iron deficiency in infants and young children. It is a simple, easy, reliable and quick method.