HemoCue@hb301仪检测人血红蛋白在现场调查中的适用性研究  

Evaluation of the Application of HemoCue@hb301 for the Human Hemoglobin Detection in the Field Investigation

作　　者：王笑笑 冯欣宇[1] 周水森[1] 黄芳[1] WANG Xiao-xiao;FENG Xin-yu;ZHOU Shui-sen;HANG Fang(National Institute of Parasitic Diseases,Chinese Center for Disease Control and Prevention,WHO Collaborating Center for Tropical Disease,National Center for International Research on Tropical Diseases,Ministry of Science and Technology,Key Laboratory of Parasite and Vector Biology,Ministry of Health,Shanghai 200025,China;Zhejiang Province Center for Disease Control and Prevention,Hangzhou 310051,China)

机构地区：[1]中国疾病预防控制中心寄生虫病预防控制所/世界卫生组织热带病合作中心/科技部国家级热带病国际联合研究中心/卫生部寄生虫病原与媒介生物学重点实验室,上海200025 [2]浙江省疾病预防控制中心,杭州310051

出　　处：《现代检验医学杂志》2021年第1期100-104,共5页Journal of Modern Laboratory Medicine

基　　金：上海市自然科学基金面上项目(No.18ZR1443400);“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(No.2018ZX10101002-002);美国国立卫生院/美国国家过敏和传染病研究所U19项目(No.U19AI129386)。

摘　　要：目的比较HemoCue@hb301仪(以下简称HemoCue仪)和Sysmex全自动血液分析仪测定血红蛋白水平的相关性和一致性,评估HemoCue仪检测血红蛋白(hemoglobin,Hb)应用于现场人群调查的适用性。方法用HemoCue仪和Sysmex全自动血液分析仪对相同的100例人体全血标本进行检测,比较两者测定的Hb值的相关性和一致性。采用随机数字法选取45份标本并分成3组,每份标本再平均分成4份,分别在常温,-4℃与-20℃条件下储存不同时间(12,24,36和48h)后用HemoCue仪测定Hb含量,比较不同储存温度和时间对检测结果的影响。结果两种方法的检测结果具有较好的相关性,r=0.995,但HemoCue仪测定值较Sysmex高,两者差异有统计学意义(t=11.471,P<0.001)。两种方法的一致性较好,LoA为(1.8,14.4)。HemoCue仪诊断贫血的灵敏度为58.62%,特异度为100%,阳性预测值为100%,阴性预测值为85.54%。三次重复测量的组间相关系数ICC为0.996,95%CI 0.993~0.997。常温下与-20℃下分别储存0~48 h后,Hb值略有升高趋势。4℃组储存条件下Hb含量相对稳定。结论HemoCue仪在检测Hb含量有较好的一致性和稳定性,适合于现场应用。Objective To compare hemoglobin concentrations by HemoCue@hb301 and Sysmex automated hematology analyzer and evaluate the application of HemoCue for testing human hemoglobin in the field investigation.Methods A total of 100 blood samples were collected for determination of Hb concentration by HemoCue and Sysmex analyzer.Agreement between the two methods was estimated using Bland-Altman plots,ICC and CCC.Forty-five samples were selected randomly and divided into three groups,and each sample was divided into 4 equal aliquots.Each aliquot was stored at room temperature,-4℃and-20℃for 12,24,36 and 48h,respectively,and then tested by HemoCue.Effects of storage temperature and duration on the Hb level detection were compared.Results A good correlation was obtained between two devices(r=0.995).HemoCue showed a significantly higher Hb level than Sysmex the difference between the two was statistically significant(t=11.471,P<0.001).Limit of agreement(LoA)between these two instruments was from 1.8 to14.4 by Bland-Altman plots.The sensitivity,specificity,positive and negative predictive values for HemoCue were 58.62%,100%,100%and 85.54%,respectively.ICC for repeated measures was 0.996,with 95%CI 0.993~0.997.Hb level was relatively stable at 4℃for 0~48 h,while increasing at room temperature or-20℃.Conclusion HemoCue is a suitable tool for the human hemoglobin detection in the field investigation.

关 键 词：血红蛋白 HemoCue仪 适用性 现场调查 

分 类 号：R446[医药卫生—诊断学]