血液荧光测定仪性能评价及其在IDA诊断中的应用

Performance evaluation of the AVIV 206D Zinc Protoporphyrin Hematof1uorometer and application of ZPP to diagnose IDA

目的评价进口AVIV206D型血液荧光测定仪性能,并探讨血液锌原卟啉(ZPP)在健康人群中的分布及ZPP在住院病人缺铁性贫血(IDA)诊断中的应用价值。方法对进口AVIV206D型血液荧光测定仪的精密度及静脉血样本ZPP稳定性进行评价;收集1 908名健康体检者和100名住院病人静脉血,测定其ZPP水平,同时收集其血常规和生化常规结果。结果本仪器测定ZPP低、中、高水平的批内精密度(CV%)分别为6.9%、9.4%、4.3%,批间精密度(CV%)分别为9.8%、5.4%、2.7%;样本置于室温保存24 h、48 h,4℃保存7 d和14 d后测定,结果与立即测定结果间无显著性差异;ZPP在健康成人中呈非正态分布,且存在性别差异(t=12.106,P<0.000 1),其中男性较女性低;健康成人和住院贫血病人ZPP水平存在统计学差异(t=12.342,P<0.000 1);在贫血病人和健康人群中,ZPP与Hb均呈显著负相关,相关系数分别为r=-0.516(P<0.000 1)和-0.306(P<0.000 1);分别以TIBC、MCV、SI和ZPP为IDA诊断指标绘制受试者工作(ROC)曲线,各指标曲线下面积(AUC)分别为0.862、0.812、0.750、0.629。结论 AVIV 206D型血液荧光测定仪性能较好,在健康人群IDA筛查中具有一定价值,但应注意ZPP用于住院病人IDA诊断时存在一些干扰因素。

Objective To estimate the performance characteristics of the AVIV 206D Zinc Protoporphyrin（ZPP） Hematofluorometer and to study the distribution of ZPP in healthy people and its diagnostic performance in iron deficiency anemia（IDA） in hospitalized patients.Methods The within-day variation and the day-to-day variation were determined by AVIV 206D Zinc Protoporphyrin Hematof1uorometer;The effects of various storage conditions were investigated by measuring ZPP in whole venous blood samples at fast and after storage at room temperature for 24 h,48 h and 4℃ for 7 d,14 d;The whole blood samples of 1 908 apparently healthy people and 100 hospitalized patients with IDA were analyzed by AVIV 206D Zinc Protoporphyrin Hematof1uorometer and simultaneously we collected their results of routine analysis of biochemistry and blood.Results The coefficient variances（CV） of within-day precision were 6.9%,9.4%,4.3% and the day-to-day precision were 9.8%,5.4%,2.7% in low/medium/high level respectively;ZPP level did not change significantly when stored at room temperature for 24 h and 48h and at 4℃ for 7 days and 14 days;The distribution of ZPP in healthy people was not normal and it was significantly different in females and males（t=12.106,P0.000 1）,higher in females;There was also significantly different for ZPP in healthy people and hospitalized patients（t=12.342,P0.000 1）;ZPP had significant negative correlations with Hb in both healthy and hospitalized people and the correlation coefficients were r=-0.516（P0.000 1） and 0.306（P0.000 1）,respectively;The area under curve（AUC） of receiver operating characteristic（ROC） curves for TIBC/MCV/SI and ZPP are 0.862,0.812,0.750,0.629 respectively.Conclusion The AVIV 206D Zinc Protoporphyrin Hematof1uorometer has good performance and maybe useful for IDA screening in healthy population,but there are some interference factors on diagnosing IDA in hospitalized patients.