Open AccessActual condition survey regarding mismatch of measurements between radioimmunoassay and enzyme‐linked immunosorbent assay tests for anti‐glutamic acid decarboxylase antibody in real‐world clinical practice
Author(s) -
Oikawa Yoichi,
Kondo Takuma,
Shimada Akira,
Seino Yutaka,
Kitaoka Masafumi
Publication year - 2019
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12955
Subject(s) - medicine , radioimmunoassay , autoantibody , glutamate decarboxylase , diabetes mellitus , antibody , clinical practice , confusion , type 1 diabetes , immunology , enzyme , endocrinology , biochemistry , physical therapy , psychology , psychoanalysis , chemistry
Abstract Anti‐glutamic acid decarboxylase antibody ( GADA ) is an important islet cell‐associated autoantibody for the diagnosis of autoimmune type 1 diabetes mellitus. In Japan, the GADA assay kit was recently changed from radioimmunoassay ( RIA ) to enzyme‐linked immunosorbent assay ( ELISA ). Thereafter, a mismatched measurement between the two tests became apparent in clinical situations. The present study aimed to clarify the actual extent of mismatch between the two measurements on a larger‐scale real‐world clinical practice. In this cross‐sectional non‐local/non‐hospital‐based study, we collected anonymized data on GADA levels of 598 participants, who were simultaneously measured with GADA ‐ RIA and GADA enzyme‐linked immunosorbent assay tests. We found that 34% of the GADA ‐ RIA ‐positive participants showed negative results in the GADA enzyme‐linked immunosorbent assay test; the mismatch was predominantly observed in participants with relatively low GADA ‐ RIA levels (<32 U/ mL ). This considerable mismatch might lead to physicians’ confusion in diagnosing type 1 diabetes mellitus.