REF-XT01型尿酸测试仪的准确性及临床应用研究  

Accuracy and clinical application of a REF-XT01 uric acid meter

作　　者：李脉超 贺玉伟 李海龙[2] 路杰[1] 张洁[1] 王雪峰[1] 任伟[1] 王灿[1] 庞磊[1] 王明[1] 李长贵[1] 纪晓朋 Li Maichao;He Yuwei;Li Hailong;Lu Jie;Zhang Jie;Wang Xuefeng;Ren Wei;Wang Can;Pang Lei;Wang Ming;Li Changgui;Ji Xiaopeng(Shandong Provincial Key Laboratory of Metabolic Disease,The Affiliated Hospital of Qingdao University,Qingdao 266003,China;Institute of Metabolic Diseases,Qingdao University,Qingdao 266003,China)

机构地区：[1]青岛大学附属医院山东省代谢性疾病重点实验室,266003 [2]青岛大学代谢病研究院,266003

出　　处：《中华内分泌代谢杂志》2020年第11期932-937,共6页Chinese Journal of Endocrinology and Metabolism

基　　金：国家自然科学基金国际(地区)合作与交流项目(81520108007);国家自然科学基金项目(81770869、81801434、31900413)。

摘　　要：目的本研究旨在评估REF-XT01型尿酸测试仪检测血尿酸浓度的准确性,以判断该尿酸测试仪检测结果能否用于指导痛风患者降尿酸药物的调整。方法对青岛大学附属医院痛风病临床医学中心就诊的1551例受试者,空腹采集静脉血,用全自动生化分析仪测定血尿酸浓度,同时采集指尖末梢血用REF-XT01型尿酸测试仪测定血尿酸浓度。应用线性回归、组内相关系数(ICC)、Bland-Altman分析法评估全自动生化分析仪血尿酸浓度(sUABA)检测值和尿酸测试仪血尿酸浓度(sUAUM)检测值间的相关性。使用受试者操作特性曲线(ROC曲线),评估sUAUM能否用于指导痛风患者的降尿酸用药。结果回归分析表明sUABA和sUAUM之间有良好的相关性,Y=0.875X+39.525(r=0.84,P<0.01);ICC为0.829(95%CI 0.814~0.844,P<0.01);Bland-Altman图显示sUABA和sUAUM具有较好的一致性,绝对偏差95%一致性界限(95%LoA)-143.4~114.5μmol/L,平均偏差-14.4μmol/L。以300μmol/L作为尿酸测试仪的检测临界值,灵敏度为96.61%,特异度为48.81%,ROC曲线下面积(AUC)为0.926(P<0.01),而以360μmol/L作为检测临界值,灵敏度为90.98%,特异度为66.78%,AUC为0.914(P<0.01)。结论REF-XT01型尿酸测试仪具有较高的精确度,其检测血尿酸数值可用于指导痛风患者降尿酸药物的调整。Objective This study aimed to evaluate the accuracy of a portable REF-XT01 uric acid meter in measuring blood uric acid concentration,and to determine whether the results of the uric acid meter could be used to guide the adjustment of uric acid-lowering drugs.Methods 1551 subjects were enrolled from the Gout Clinical Medical Center of the Affiliated Hospital of Qingdao University.The fasting venous blood was collected and the serum uric acid was measured by an automatic biochemical analyzer.Meanwhile,the capillary blood uric acid was measured by fingertip puncture using the REF-XT01 uric acid meter.Linear regression,intra-group correlation coefficient(ICC),and Bland-Altman plots were used to analyze the uric acid concentration correlation between the biochemical analyzer(sUABA)and the uric acid meter(sUAUM).The receiver operating characteristic curve(ROC curve)was conducted to evaluate whether sUAUM can be used as a reference for the gout patients to take uric acid-lowering drugs.Results The regression analysis showed correlation between sUABA and sUAUM,with the regression formula Y=0.875X+39.525(r=0.84,P<0.01)and the ICC was 0.829(95%CI 0.814-0.844,P<0.01).The Bland-Altman diagram showed a good consistence(the absolute deviation was-143.4-114.5μmol/L,mean deviation was-14.4μmol/L)between sUABA and sUAUM.The sensitivity was 96.61%,specificity was 48.81%,and the area under the ROC curve(AUC)was 0.926(P<0.01)when 300μmol/L was defined as the detection threshold of the uric acid meter,the sensitivity was 90.98%,specificity was 66.78%,and the area under the ROC curve(AUC)was 0.914(P<0.01)when 360μmol/L was defined as the detection threshold of the uric acid meter.Conclusion REF-XT01 uric acid meter is applicable for the adjustment of uric acid-lowering drugs for the gout patients,because of its high accuracy for the detection of uric acid.

关 键 词：尿酸测试仪 痛风 降尿酸药物 

分 类 号：R589.7[医药卫生—内分泌]