Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan

In Japan, the traditional method for measuring plasma aldosterone concentration (PAC) was radioimmunoassay (RIA), which had several challenges, including poor traceability of certified reference materials and reduced detection sensitivity at low concentrations. To overcome these issues, a chemilumin...

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Main Authors: Ken-ichiro Honma, Yoshiro Nakayama, Atsuko Tamaki, Moriyuki Uehara, Taiki Teruya, Takamitsu Yabiku, Yohei Ishiki, Ken Yonaha, Rei Chinen, Tsugumi Uema, Shiki Okamoto, Hiroaki Masuzaki
Format: Article
Language:English
Published: The Japan Endocrine Society 2024-09-01
Series:Endocrine Journal
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Online Access:https://www.jstage.jst.go.jp/article/endocrj/71/9/71_EJ24-0227/_html/-char/en
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author Ken-ichiro Honma
Yoshiro Nakayama
Atsuko Tamaki
Moriyuki Uehara
Taiki Teruya
Takamitsu Yabiku
Yohei Ishiki
Ken Yonaha
Rei Chinen
Tsugumi Uema
Shiki Okamoto
Hiroaki Masuzaki
author_facet Ken-ichiro Honma
Yoshiro Nakayama
Atsuko Tamaki
Moriyuki Uehara
Taiki Teruya
Takamitsu Yabiku
Yohei Ishiki
Ken Yonaha
Rei Chinen
Tsugumi Uema
Shiki Okamoto
Hiroaki Masuzaki
author_sort Ken-ichiro Honma
collection DOAJ
description In Japan, the traditional method for measuring plasma aldosterone concentration (PAC) was radioimmunoassay (RIA), which had several challenges, including poor traceability of certified reference materials and reduced detection sensitivity at low concentrations. To overcome these issues, a chemiluminescent enzyme immunoassay (CLEIA) for PAC measurement was introduced in April 2021 and the Japan Endocrine Society published new guidelines for primary aldosteronism (PA). This study aimed to evaluate the impact of the transition from RIA to CLEIA for PAC measurement on PA diagnosis. Data from 190 patients admitted to the Second Department of Internal Medicine, University of the Ryukyus Hospital, between April 2012 and March 2021 were analyzed. Patients who were diagnosed with PA underwent adrenal venous sampling. The PAC measured by RIA (PAC(RIA)) was converted to the estimated PAC measured by CLEIA (ePAC(CLEIA)) using a conversion formula. The present study evaluated the discordance rates in diagnoses based on screening (SC), captopril challenge test (CCT), saline infusion test (SIT), and diagnosis of PA between results judged by PAC(RIA) according to the previous guidelines and those judged by ePAC(CLEIA) according to the new guidelines. The results revealed discordant diagnosis rates of 6.4% for SC and 10.1% for CCT, with no discordance for SIT. The discordant diagnosis rate for PA was 3.7%. Our study reveals the challenges in establishing appropriate diagnostic criteria for PA using PAC(CLEIA) and highlights the demand for further research on provisionally positive categories.
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institution Kabale University
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spelling doaj-art-7a654cf94f49449d8ff46be752ce9e152025-01-22T05:20:11ZengThe Japan Endocrine SocietyEndocrine Journal1348-45402024-09-0171989590610.1507/endocrj.EJ24-0227endocrjImpact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, JapanKen-ichiro Honma0Yoshiro Nakayama1Atsuko Tamaki2Moriyuki Uehara3Taiki Teruya4Takamitsu Yabiku5Yohei Ishiki6Ken Yonaha7Rei Chinen8Tsugumi Uema9Shiki Okamoto10Hiroaki Masuzaki11Division of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanDivision of Endocrinology, Diabetes and Metabolism, Hematology and Rheumatology, Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, JapanIn Japan, the traditional method for measuring plasma aldosterone concentration (PAC) was radioimmunoassay (RIA), which had several challenges, including poor traceability of certified reference materials and reduced detection sensitivity at low concentrations. To overcome these issues, a chemiluminescent enzyme immunoassay (CLEIA) for PAC measurement was introduced in April 2021 and the Japan Endocrine Society published new guidelines for primary aldosteronism (PA). This study aimed to evaluate the impact of the transition from RIA to CLEIA for PAC measurement on PA diagnosis. Data from 190 patients admitted to the Second Department of Internal Medicine, University of the Ryukyus Hospital, between April 2012 and March 2021 were analyzed. Patients who were diagnosed with PA underwent adrenal venous sampling. The PAC measured by RIA (PAC(RIA)) was converted to the estimated PAC measured by CLEIA (ePAC(CLEIA)) using a conversion formula. The present study evaluated the discordance rates in diagnoses based on screening (SC), captopril challenge test (CCT), saline infusion test (SIT), and diagnosis of PA between results judged by PAC(RIA) according to the previous guidelines and those judged by ePAC(CLEIA) according to the new guidelines. The results revealed discordant diagnosis rates of 6.4% for SC and 10.1% for CCT, with no discordance for SIT. The discordant diagnosis rate for PA was 3.7%. Our study reveals the challenges in establishing appropriate diagnostic criteria for PA using PAC(CLEIA) and highlights the demand for further research on provisionally positive categories.https://www.jstage.jst.go.jp/article/endocrj/71/9/71_EJ24-0227/_html/-char/enhypertensionprimary aldosteronismplasma aldosterone concentrationradioimmunoassaychemiluminescent enzyme immunoassay
spellingShingle Ken-ichiro Honma
Yoshiro Nakayama
Atsuko Tamaki
Moriyuki Uehara
Taiki Teruya
Takamitsu Yabiku
Yohei Ishiki
Ken Yonaha
Rei Chinen
Tsugumi Uema
Shiki Okamoto
Hiroaki Masuzaki
Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
Endocrine Journal
hypertension
primary aldosteronism
plasma aldosterone concentration
radioimmunoassay
chemiluminescent enzyme immunoassay
title Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
title_full Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
title_fullStr Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
title_full_unstemmed Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
title_short Impact of the transition from radioimmunoassay (RIA) to chemiluminescent enzyme immunoassay (CLEIA) for the measurement of plasma aldosterone concentration (PAC) on the diagnosis of primary aldosteronism (PA) via retrospective analyses in Okinawa, Japan
title_sort impact of the transition from radioimmunoassay ria to chemiluminescent enzyme immunoassay cleia for the measurement of plasma aldosterone concentration pac on the diagnosis of primary aldosteronism pa via retrospective analyses in okinawa japan
topic hypertension
primary aldosteronism
plasma aldosterone concentration
radioimmunoassay
chemiluminescent enzyme immunoassay
url https://www.jstage.jst.go.jp/article/endocrj/71/9/71_EJ24-0227/_html/-char/en
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