Liu Zhi, Zhang Mei, Ren Yan, Chen Tao, Gao Hong-Jiao, He He, Liu Ying, An Zhen-Mei
Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.
Sichuan Da Xue Xue Bao Yi Xue Ban. 2021 May;52(3):472-476. doi: 10.12182/20210560505.
To evaluate the performance of chemiluminescence immunoassay (CLIA) in examining renin and aldosterone and to determine its value for screening for primary aldosteronism (PA).
According to the relevant documents of Clinical and Laboratory Standards Institute (CLSI), we verified the precision, linear range and carryover rate of examining renin and aldosterone with CLIA. The study included 91 suspected PA patients, using two methods, CLIA and radioimmunoassay (RIA), to examine renin and aldosterone levels in order to compare the correlation between the two methods and their value for PA screening.
The precision, linear range and carryover rate of examining renin and aldosterone with CLIA met the requirements. In patients with suspected PA, the correlation coefficients of renin, aldosterone and aldosterone-to-renin ratio (ARR) assessed by CLIA and RIA were 0.901, 0.861 and 0.847 respectively (all <0.001). When the patients were in the upright position and the ARR was 5.636 (ng/dL)/(ng/L), the CLIA method had 79.1% sensitivity and 93.7% specificity for PA screening; when ARR was 14.084 (ng·dL )/(ng·[mL·h] ), the RIA method had 93.0% sensitivity and 83.3% specificity for PA screening. When the patients were in the supine position, and the ARR was 5.640 (ng/dL)/(ng/L), the CLIA method had 97.7% sensitivity and 81.2% specificity for PA screening; when ARR was 33.494 (ng·dL )/(ng·[mL·h] ), RIA had 95.3% sensitivity and 70.8% specificity for PA screening .
The performance of the CLIA kit in assessing the concentration of renin and aldosterone meets the clinical requirements. Regarding preliminary PA screening, upright-position ARR had higher specificity, but lower sensitivity compared with supine-position ARR.
评估化学发光免疫分析法（CLIA）检测肾素和醛固酮的性能，并确定其在原发性醛固酮增多症（PA）筛查中的价值。
根据临床和实验室标准协会（CLSI）的相关文件，我们验证了CLIA检测肾素和醛固酮的精密度、线性范围及携带污染率。该研究纳入91例疑似PA患者，采用CLIA和放射免疫分析法（RIA）两种方法检测肾素和醛固酮水平，以比较两种方法之间的相关性及其在PA筛查中的价值。
CLIA检测肾素和醛固酮的精密度、线性范围及携带污染率均符合要求。在疑似PA患者中，CLIA和RIA评估的肾素、醛固酮及醛固酮/肾素比值（ARR）的相关系数分别为0.901、0.861和0.847（均<0.001）。当患者处于立位且ARR为5.636（ng/dL）/（ng/L）时，CLIA法筛查PA的灵敏度为79.1%，特异度为93.7%；当ARR为14.084（ng·dL）/（ng·[mL·h]）时，RIA法筛查PA的灵敏度为93.0%，特异度为83.3%。当患者处于卧位且ARR为5.640（ng/dL）/（ng/L）时，CLIA法筛查PA的灵敏度为97.7%，特异度为81.2%；当ARR为33.494（ng·dL）/（ng·[mL·h]）时，RIA法筛查PA的灵敏度为95.3%，特异度为70.8%。
CLIA试剂盒评估肾素和醛固酮浓度的性能符合临床要求。对于PA初步筛查，立位ARR的特异度较高，但与卧位ARR相比灵敏度较低。
