Impact of a change to a novel chemiluminescent immunoassay for measuring plasma aldosterone on the diagnosis of primary aldosteronism
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- Kobayashi Hiroki
- Division of Nephrology, Hypertension, and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo 173-8610, Japan
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- Nakamura Yoshihiro
- Division of Nephrology, Hypertension, and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo 173-8610, Japan
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- Abe Masanori
- Division of Nephrology, Hypertension, and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo 173-8610, Japan
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- Tanabe Akiyo
- Division of Endocrinology, National Center for Global Health and Medicine, Tokyo 162-8655, Japan
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- Sone Masakatsu
- Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan
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- Katabami Takuyuki
- Division of Metabolism and Endocrinology, Department of Internal Medicine, St Marianna University School of Medicine Yokohama City Seibu Hospital, Yokohama 241-0811, Japan
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- Kurihara Isao
- Department of Medical Education, National Defense Medical College, Tokorozawa 359-8513, Japan Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine, Tokyo 160-8582, Japan
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- Ichijo Takamasa
- Department of Endocrinology and Metabolism, Saiseikai Yokohamashi Tobu Hospital, Yokohama 230-8765, Japan
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- Tsuiki Mika
- Department of Endocrinology and Metabolism, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan
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- Izawa Shoichiro
- Division of Endocrinology and Metabolism, Tottori University Faculty of Medicine, Yonago 683-8504, Japan
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- Wada Norio
- Department of Diabetes and Endocrinology, Sapporo City General Hospital, Sapporo 060-8604, Japan
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- Yoneda Takashi
- Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa 920-0934, Japan
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- Takahashi Katsutoshi
- Division of Metabolism, Showa General Hospital, Kodaira 187-0002, Japan
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- Tamura Kouichi
- Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan
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- Ogawa Yoshihiro
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
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- Inagaki Nobuya
- Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto 606-8507, Japan
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- Yamamoto Koichi
- Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita 565-0871, Japan
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- Rakugi Hiromi
- Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita 565-0871, Japan
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- Naruse Mitsuhide
- Department of Endocrinology and Metabolism, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan Endocrine Center and Clinical Research Center, Ijinkai Takeda General Hospital, Kyoto 601-1495, Japan
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Description
<p>In Japan, the standard method for measuring plasma aldosterone concentration (PAC) for primary aldosteronism (PA) diagnosis was changed from radioimmunoassay (RIA) to a novel chemiluminescent enzyme immunoassay (CLEIA). The purpose of this study is to simulate the possible impact of the change on PA diagnosis. This retrospective study assessed 2,289 PA patients. PACs measured by conventional RIA were transformed to estimated PACs (CLEIA) as follows: RIA (pg/mL) = 1.174 × CLEIA (pg/mL) + 42.3. We applied the estimated PAC (CLEIA) to the conventional cut-off of aldosterone-to-renin activity ratio ≥200 for screening and captopril challenge test (CCT) and PAC ≥60 pg/mL for saline infusion test (SIT). Application of the estimated PAC to screening and confirmatory tests decreased the number of PA diagnoses by 36% (743/2,065) on CCT and 52% (578/1,104) on SIT (discrepant cases). Among the discrepant cases, 87% (548/628) of CCT and 87% (452/522) of SIT were bilateral on adrenal venous sampling (AVS). Surgically treatable aldosterone-producing adenomas (APAs) were observed in 6% (36/579) and 5% (23/472) of discrepant cases on CCT and SIT, respectively; most were characterized by hypokalemia and/or adrenal nodule on CT imaging. Application of the PAC measured by the novel CLEIA to conventional cut-offs decreases the number of PA diagnoses. Although most discrepant cases were bilateral on AVS, there are some APA cases that were characterized by hypokalemia and/or adrenal tumor on CT. Further studies which evaluate PACs measured by both RIA and CLEIA for each patient are needed to identify new cut-offs for PAC measured by CLEIA.</p>
Journal
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- Endocrine Journal
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Endocrine Journal 70 (5), 489-500, 2023
The Japan Endocrine Society
