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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.

journal of diabetes investigation

Actual 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