化学发光免疫法检测醛固酮和肾素浓度及对原发性醛固酮增多症诊断价值的评价

摘要

Objective: To evaluate chemiluminescence immunoassay (CLIA) for detecting blood levels of aldosterone and rennin with its diagnostic value of primary aldosteronism (PA) with comparison to radio immunoassay (RIA). Methods: According to American protocols of CLSI, we conducted a veriifcation study between RIA and CLIA for their precision, accuracy, linearity and reference ranges; meanwhile, taking clinical diagnosis as golden standard, examined renin activity or concentration and aldosterone concentration in 20 healthy volunteers and 40 hypertension patients by both RIA and CLIA, compared the ratios of ARR (aldosterone concentration/renin activity) or ADRR (aldosterone concentration/renin concentration) for the speciifcity and sensitivity of PA diagnosis. Results: Within-lot and between-lot accuracies of CLIA for detecting aldosterone levels were below 5% and 10%, the recoveries were 102% and 95% respectively. There was a good linear correlation in the range of aldosterone at (3-74) ng/dl and renin at (0.99-330) µIU/ml. In healthy volunteers, renin level was higher in 2 subjects, while aldosterone level and ADRR ratio were within normal references in all subjects by the manufacturer. In hypertension patients, the sensitivity and speciifcity for aldosterone and rennin detections by CLIA were at 85.7% and 97.0%, by RIA were at 85.7% and 94.0%. Conclusion: CLIA has the superiority of simple performance, repeatable and without radioactive contamination; it is recommended for replacing RIA as necessity.%目的：对化学发光免疫法（CLIA）检测醛固酮和肾素浓度进行方法学评价，并通过和放射免疫法（RIA）比较评价其对原发性醛固酮增多症（原醛）的诊断价值。方法：依据美国临床实验室标准化协会的相关方案，对CLIA检测醛固酮和肾素浓度的精密度、准确性、线性范围及参考值范围进行评价和验证，同时对40例高血压原因待查患者分别用RIA和CLIA检测肾素活性或肾素浓度及醛固酮浓度，以临床诊断为金标准，比较两种方法测得的醛固酮浓度/肾素活性或浓度的比值（ARR或ADRR）用于原醛诊断的特异性和敏感性。结果：CLIA检测醛固酮和肾素浓度的批内和批间精密度分别小于5%和10%；回收率分别为102%和95%；醛固酮浓度在3~74 ng/dl范围内、肾素浓度在0.99~330.00µIU/ml范围内，线性关系良好；20例健康受试者除2例肾素浓度超过参考值范围，20例醛固酮浓度和ADRR均在厂商提供的正常人参考范围内。高血压原因待查患者的筛查试验结果显示CLIA和RIA的检测敏感性相同，为85.7%，特异性则分别为97.0%和94.0%。结论：CLIA具有操作简单、重复性好、无放射性污染等优点，CLIA的检测结果符合临床要求，厂商提供的正常参考值范围可用于临床，本研究推荐用CLIA替代RIA。