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刘稚, 张玫, 任艳, 等. 肾素、醛固酮化学发光免疫法检测的性能验证及筛查原发性醛固酮增多症的价值[J]. 四川大学学报（医学版）, 2021, 52(3): 472-476. DOI: 10.12182/20210560505
引用本文: 刘稚, 张玫, 任艳, 等. 肾素、醛固酮化学发光免疫法检测的性能验证及筛查原发性醛固酮增多症的价值[J]. 四川大学学报（医学版）, 2021, 52(3): 472-476. DOI: 10.12182/20210560505
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LIU Zhi, ZHANG Mei, REN Yan, et al. Performance Verification of Plasma Renin and Aldosterone Examination with Chemiluminescence Immunoassay and Its Screening Efficacy for Primary Aldosteronism[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(3): 472-476. DOI: 10.12182/20210560505
Citation: LIU Zhi, ZHANG Mei, REN Yan, et al. Performance Verification of Plasma Renin and Aldosterone Examination with Chemiluminescence Immunoassay and Its Screening Efficacy for Primary Aldosteronism[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(3): 472-476. DOI: 10.12182/20210560505
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肾素、醛固酮化学发光免疫法检测的性能验证及筛查原发性醛固酮增多症的价值

Performance Verification of Plasma Renin and Aldosterone Examination with Chemiluminescence Immunoassay and Its Screening Efficacy for Primary Aldosteronism

    摘要
  • 摘要:
      目的  验证化学发光免疫法（CLIA）检测肾素、醛固酮的性能及筛查原发性醛固酮增多症（原醛症）的价值。
      方法  根据美国临床实验室标准化协会相关文件验证CLIA检测肾素、醛固酮的精密度、线性范围和携带污染率。纳入91例疑似原醛症的患者，分别采用CLIA、放射免疫法（RIA）检测肾素和醛固酮，比较两种方法的相关性和对原醛症的筛查价值。
      结果  CLIA法检测肾素、醛固酮的精密度、线性范围和携带污染率均符合要求。在疑似原醛症患者中，CLIA法和RIA法检测出的肾素、醛固酮和醛固酮/肾素（ARR）水平的相关系数分别为0.901、0.861、0.847（P均<0.001）。患者立位状态下，ARR为5.636 (ng/dL)/(ng/L)时，CLIA法筛查原醛症灵敏度为79.1%，特异度为93.7%；ARR为14.084 (ng·dL－1)/〔ng·（mL·h）－1〕时，RIA法筛查原醛症灵敏度为93.0%，特异度为83.3%。卧位状态下，ARR为5.640 (ng/dL)/(ng/L)时，CLIA法筛查原醛症灵敏度为97.7%，特异度为81.2%；ARR为33.494 (ng·dL－1)/〔ng·（mL·h）－1〕时，RIA法筛查原醛症灵敏度为95.3%，特异度为70.8%。
      结论  CLIA法检测肾素、醛固酮的性能均满足临床要求，立位ARR初筛原醛症的特异性相比卧位ARR更高，敏感性较低。

     

    Abstract:
      Objective  To evaluate the performance of chemiluminescence immunoassay (CLIA) in examining renin and aldosterone and to determine its value for screening for primary aldosteronism (PA).
      Methods  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.
      Results  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 P<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－1)/(ng·mL·h－1), 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－1)/(ng·mL·h－1), RIA had 95.3% sensitivity and 70.8% specificity for PA screening .
      Conclusion  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.

     

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