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在原发性醛固酮增多症的筛查和诊断中,自动化化学发光免疫分析仪与传统放射免疫分析比较血浆醛固酮和肾素数据。

Comparisons of plasma aldosterone and renin data between an automated chemiluminescent immunoanalyzer and conventional radioimmunoassays in the screening and diagnosis of primary aldosteronism.

机构信息

Research Support Center, Shizuoka General Hospital, Shizuoka, Shizuoka, Japan.

Center for Diabetes, Endocrinology and Metabolism, Shizuoka General Hospital, Shizuoka, Shizuoka, Japan.

出版信息

PLoS One. 2021 Jul 9;16(7):e0253807. doi: 10.1371/journal.pone.0253807. eCollection 2021.

Abstract

Determining values of plasma renin activity (PRA) or plasma active renin concentration (ARC), plasma aldosterone concentration (PAC), and aldosterone-to-renin ratio (ARR) is essential to diagnose primary aldosteronism (PA), but it takes several days with conventional radioimmunoassays (RIAs). Chemiluminescent enzyme immunoassays for PAC and ARC using the Accuraseed® immunoanalyzer facilitated the determination, but relations between Accuraseed® immunoanalyzer-based and RIA-based values in samples of PA confirmatory tests and adrenal venous sampling remained to be elucidated. We addressed this issue in the present study. This is a prospective, cross-sectional study. ARC and PAC values were measured by the Accuraseed® immunoanalyzer in samples, in which PRA and PAC values had been measured by the PRA-FR® RIA and SPAC®-S Aldosterone kits, respectively. The relations between Accuraseed® immunoanalyzer-based and RIA-based values were investigated with regression analyses. The optimal cutoff of Accuraseed® immunoanalyzer-based ARR for PA screening was determined by the receiver operating characteristic analysis. After log-log transformations, linear relations with high coefficients of determination were observed between Accuraseed® immunoanalyzer-based and RIA-based data of renin and aldosterone. Following the PA guidelines of Japan Endocrine Society, Accuraseed® immunoanalyzer-based cutoffs were calculated from the regression equations: the basal PAC for PA screening >12 ng/dL, PAC for the saline infusion test >8.2 ng/dL, ARC for the furosemide-upright test <15 pg/mL, and ARR for the captopril challenge test >3.09 ng/dL per pg/mL. The optimal cutoff of Accuraseed® immunoanalyzer-based ARR for PA screening was >2.43 ng/dL over pg/mL not to overlook bilateral PA patients. The present study provided conversion formulas between Accuraseed® immunoanalyzer-based and RIA-based values of renin, aldosterone, and ARR, not only in basal samples but also in samples of PA confirmatory tests and adrenal venous sampling. Although validation studies are awaited, the present study will become priming water of harmonization of renin and aldosterone immunoassays.

摘要

测定血浆肾素活性(PRA)或血浆活性肾素浓度(ARC)、血浆醛固酮浓度(PAC)和醛固酮与肾素比值(ARR)对于诊断原发性醛固酮增多症(PA)至关重要,但使用传统放射免疫分析(RIA)需要数天时间。使用 Accuraseed®免疫分析仪进行 PAC 和 ARC 的化学发光酶免疫分析有助于确定这些值,但在 PA 确认性测试和肾上腺静脉采样的样本中,Accuraseed®免疫分析仪与 RIA 之间的关系仍有待阐明。本研究旨在解决这一问题。这是一项前瞻性的横断面研究。分别使用 PRA-FR® RIA 和 SPAC®-S Aldosterone 试剂盒测量样本中的 PRA 和 PAC 值,使用 Accuraseed®免疫分析仪测量 ARC 和 PAC 值。通过回归分析研究了 Accuraseed®免疫分析仪与 RIA 之间的关系。通过受试者工作特征分析确定 Accuraseed®免疫分析仪 ARR 用于 PA 筛查的最佳截断值。经过对数-对数转换,Accuraseed®免疫分析仪和 RIA 数据的肾素和醛固酮之间存在高度确定系数的线性关系。根据日本内分泌学会的 PA 指南,从回归方程中计算出 Accuraseed®免疫分析仪的切点:PA 筛查的基础 PAC>12ng/dL,盐水输注试验的 PAC>8.2ng/dL,呋塞米直立试验的 ARC<15pg/mL,卡托普利挑战试验的 ARR>3.09ng/dL/ pg/mL。Accuraseed®免疫分析仪 ARR 的最佳截断值为>2.43ng/dL/ pg/mL,以不忽略双侧 PA 患者。本研究提供了 Accuraseed®免疫分析仪和 RIA 之间肾素、醛固酮和 ARR 值的转换公式,不仅适用于基础样本,也适用于 PA 确认性测试和肾上腺静脉采样的样本。尽管需要进一步的验证研究,但本研究将成为肾素和醛固酮免疫分析协调的基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d20a/8270132/f1de26a19e06/pone.0253807.g001.jpg

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