比较两种化学发光法测定的血浆醛固酮/肾素浓度比值筛查原醛症的价值

Comparison of the ratio of plasma aldosterone to renin concentrationmeasured by two chemiluminescentimmunoassays in screening for primary aldosteronism

目的比较两种化学发光法(进口/国产试剂盒)测定血浆醛固酮浓度/肾素浓度比值(ARR)筛查原发性醛固酮增多症(原醛)的价值。方法本研究纳入2017年12月至2018年10月就诊于重庆医科大学附属第一医院内分泌科行原醛筛查的高血压患者228例,其中164例原发性高血压患者,64例原醛患者。同时采用进口(意大利索灵公司)和国产(深圳迈瑞公司)化学发光法试剂盒测定立位血浆醛固酮浓度(PAC)、肾素浓度(PRC),并计算ARR。通过构建ROC曲线比较两者筛査效能,根据Youden's指数选择ARR筛査原醛的最佳切点。结果进口试剂盒检测立位ARR的ROC曲线下面积(AUCROC)是0.937(95%CI0.897〜0.965,PvO.OOO 1),国产试剂盒检测立位ARR的AUCROC是0.942(95%CI0.903-0.968,P<0.0001);两者ROC曲线下面积差异为0.00457(95%CI-0.0210-0.0302,P=0.7263)。进口试剂盒检测ARR的最大Youden's指数为0.749,对应切点为12.8(pg/ml)(μU/ml),灵敏度为96.87%,特异度为78.05%;国产试剂盒检测ARR的最大Youden*s指数为0.756,对应切点为12.5(pg/ml)/(μIU/ml),灵敏度为89.06%,特异度为86.59%。结论国产和进口化学发光法试剂盒测定立位ARR对原醛的筛查效能无差异。

Objective To compare the detection efficiency of the ratio of plasma aldosterone concentration to renin concentration(ARR)measured by imported and domestic chemiluminescent immunoassay kits for screening primary aldosteronism(PA).Methods A total of 164 patients with essential hypertension and 64 patients with PA were recruited in this study.Plasma aldosterone concentration(PAC)and renin concentration(PRC)were measured concurrently by imported chemiluminescent immunoassay kit(Diasorin,Italy)and domestic kit(Mindray,Shenzhen,China),and then ARR were calculated.A ROC curve analysis was performed to compare the screening efficacy of the two kits and the optimal ARR cut-offs for PA screening were recommended according to Youden*s index.Results The areas under the ROC curves(AUCROC)of ARR were 0.937(95%CI 0.897-0.965,PvO.0001)detected by imported kit and 0.942(95%CI 0.903-0.968,P<0.0001)detected by domestic kit.The difference of AUCROC of ARR detected by two kits was 0.00457(95%CI-0.0210-0.0302,P<0.7263).The highest Youden's indexes of ARR were 0.749(detected by imported kit)with the cut-off value of 12.8(pg/ml)/(μIU/ml)(sensitivity 96.87%,specificity 7&05%)and 0.756(detected by domestic kit)with the cut-off value of 12.5(pg/ml)/(μIU/ml)(sensitivity 89.06%,specificity 86.59%).Conclusions There was no significant difference between domestic and imported chemiluminescent immunoassays in the screening efficiency of ARR for PA.