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目的验证化学发光免疫法(CLIA)肾素、醛固酮定量试剂盒的线性、准确性、精密度等主要分析性能。方法选取高血压患者74例,其中22例PA患者,分别采用CLIA和放射免疫法(RIA)检测肾素和醛固酮,对2种检测方法的结果进行相关性分析,采用受试者工作特征曲线比较这2种方法测得的AARR和ARR比值在PA筛查中的灵敏度和特异度,以此探讨CLIA与RIA的一致性及其在临床诊断上对原发性醛固酮增多症(PA)的筛查价值。结果 CLIA法AARR以62.29为切点,灵敏度为100.0%,特异度为96.2%,约登指数为0.961 5;RIA法ARR以35.05为切点,灵敏度为95.5%,特异度为88.5%,约登指数为0.839 2。结论肾素和醛固酮化学发光定量检测试剂盒性能验证有效,符合检验科室的临床要求,CLIA和RIA 2种方法检测筛查PA具有良好的相关性,CLIA具有更高的灵敏度和特异度。
Objective To verify the linearity, accuracy and precision of chemiluminescent immunoassay (CLIA) renin and aldosterone quantification kit. Methods Totally 74 patients with hypertension were enrolled. Twenty-two patients with PA were enrolled in this study. Renal and aldosteron were detected by CLIA and radioimmunoassay (RIA) respectively. The correlation between the two methods was analyzed. These two methods measured the AARR and ARR ratio in PA screening sensitivity and specificity, in order to investigate the consistency of CLIA and RIA and its clinical diagnosis of primary aldosteronism (PA) screening value. Results AARR of CLIA was detected with a sensitivity of 100.0%, a specificity of 96.2% and a Roughness index of 0.961 5 with a cutoff of 62.29. The ARR of RIA was 95.05% with a sensitivity of 88.5% The index is 0.839 2. Conclusions The performance of the kit for quantitative determination of renin and aldosterone chemiluminescence is validated and accords with the clinical requirements of the test department. CLIA and RIA 2 methods have good correlation with screening and screening PA, CLIA has higher sensitivity and specificity.