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Adrenal venous sampling criteria for chemiluminescent enzyme immunoassay as a preferable alternative to radioimmunoassay in primary aldosteronism
Endocrine Journal ( IF 2 ) Pub Date : 2024-02-28 , DOI: 10.1507/endocrj.ej23-0695
Kazuki Nakai 1 , Yuya Tsurutani 1 , Koki Irie 1 , Kyoko Teruyama 2 , Sachiko Suematsu 1 , Seishi Matsui 3 , Kohzoh Makita 4 , Jun Saito 1 , Masao Omura 1 , Tetsuo Nishikawa 1
Affiliation  

Plasma aldosterone concentration (PAC) was routinely measured using radioimmunoassay (RIA); however, the RIA kit was discontinued in March 2021 in Japan. This study examined PAC conversion in adrenal venous sampling (AVS) and AVS criteria when measured using chemiluminescent enzyme immunoassay (CLEIA). PAC of 415 adrenal venous blood samples from AVS (including segmental AVS) of 63 patients with primary aldosteronism was measured using RIA (Spac-S aldosterone kit; Fujirebio Inc.) and CLEIA (Lumipulse Presto Aldosterone; Fujirebio Inc.). PAC of 70 AVS samples was also measured using liquid chromatography-mass spectrometry (LC-MS/MS, ASKA Pharma Medical Co., Ltd.). PAC conversion formulas were determined for each AVS sample assay. PAC measured using CLEIA was significantly correlated with that measured using RIA (correlation coefficient = 0.971). The PAC conversion formula was PAC (CLEIA) = PAC (RIA) × 0.772 – 1,199 pg/mL. The PAC of 14,000 pg/mL in RIA was equivalent to 9,613 pg/mL in CLEIA. PAC measured using CLEIA was also correlated with that measured using LC-MS/MS, and the PAC conversion formula was PAC (CLEIA, pg/mL) = 0.97 × PAC (LC-MS/MS, pg/mL) + 211. The inter-assay coefficient of variability (CV) was 1.1–1.3% and intra-assay CV was 1.0–1.7%, measured using CLEIA. The PAC conversion formula for AVS samples was obtained using CLEIA and RIA, and the conversion formula was different from that for peripheral blood. PAC values measured by CLEIA showed preferable accuracy and high concordance with those measured by LC-MS/MS, even in AVS samples. The study outcomes are useful for interpreting AVS results using non-RIA measurement methods.



中文翻译:

原发性醛固酮增多症中化学发光酶免疫分析作为放射免疫分析的优选替代方法的肾上腺静脉取样标准

血浆醛固酮浓度(PAC)采用放射免疫分析法(RIA)常规测定;然而,RIA 套件已于 2021 年 3 月在日本停产。本研究检查了肾上腺静脉采样 (AVS) 中的 PAC 转化率以及使用化学发光酶免疫分析 (CLEIA) 测量时的 AVS 标准。使用 RIA(Spac-S 醛固酮试剂盒;Fujirebio Inc.)和 CLEIA(Lumipulse Presto 醛固酮;Fujirebio Inc.)测量 63 名原发性醛固酮增多症患者的 AVS(包括节段 AVS)的 415 份肾上腺静脉血样本的 PAC。还使用液相色谱-质谱法(LC-MS/MS,ASKA Pharma Medical Co., Ltd.)测量了 70 个 AVS 样品的 PAC。为每个 AVS 样品测定确定了 PAC 转换公式。使用 CLEIA 测量的 PAC 与使用 RIA 测量的 PAC 显着相关(相关系数 = 0.971)。PAC 换算公式为 PAC (CLEIA) = PAC (RIA) × 0.772 – 1,199 pg/mL。RIA 中的 PAC 为 14,000 pg/mL,相当于 CLEIA 中的 9,613 pg/mL。使用 CLEIA 测量的 PAC 与使用 LC-MS/MS 测量的 PAC 也存在相关性,PAC 转换公式为 PAC (CLEIA, pg/mL) = 0.97 × PAC (LC-MS/MS, pg/mL) + 211。使用 CLEIA 测量,测定间变异系数 (CV) 为 1.1–1.3%,测定内 CV 为 1.0–1.7%。AVS样本的PAC换算公式是利用CLEIA和RIA得到的,与外周血的换算公式不同。即使在 AVS 样品中,CLEIA 测量的 PAC 值也显示出更好的准确性,并且与 LC-MS/MS 测量的值高度一致。研究结果有助于使用非 RIA 测量方法解释 AVS 结果。

更新日期:2024-02-27
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