Discrepancy of glutamic acid decarboxylase 65 autoantibody results between RSR radioimmunoassay and enzyme‐linked immunosorbent assay in patients with type 1 diabetes is related to autoantibody affinity

Kawasaki, Eiji; Okada, Akira; Uchida, Atsushi; Sagara, Yoko; Nakano, Yuko; Tamai, Hiroshi; Tojikubo, Masayuki; Koga, Nobuhiko

doi:10.1111/jdi.12996

Cited by 19 publications

(23 citation statements)

References 16 publications

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“…The serum GADAb titers were measured using a commercial RIA and 125 I‐labeled recombinant human GAD65 as the tracer reagent (Cosmic); patients with GADAb titers of ≥1.5 U/mL (mean in Japanese controls + 3 SD) were judged as being positive, in accordance with previous reports. The GADAb titers in the same serum specimens were then measured by ELISA using the GADAb ELISA kit (Cosmic), and patients with GADAb titers of ≥5.0 U/mL (99th percentile of the 300 normal controls) were judged as being positive, in accordance with previous reports.…”

Section: Methodsmentioning

confidence: 59%

Increased diagnosis of autoimmune childhood‐onset Japanese type 1 diabetes using a new glutamic acid decarboxylase antibody enzyme‐linked immunosorbent assay kit, compared with a previously used glutamic acid decarboxylase antibody radioimmunoassay kit

Sugihara

Yokota

Mukai

et al. 2019

J of Diabetes Invest

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Aims/Introduction: We compared the results of testing for glutamic acid decarboxylase antibodies (GADAb) using a radioimmunoassay (RIA) and an enzyme-linked immunosorbent assay (ELISA) in individuals with childhood-onset type 1 diabetes mellitus. Materials and Methods: Serum specimens were collected from 1,024 Japanese children (426 boys and 598 girls) in 2013. The median age at diagnosis was 7 years (0-18 years). The blood specimens were obtained at a median age of 13 years (2-22 years). Results: Among the 628 children whose serum specimens were collected within 5 years after diagnosis, the rate of GADAb positivity was 47.9% using RIA and 69.4% using ELISA. The participants were divided into four groups according to their RIA and ELISA results for GADAb as follows: group I (RIA+/ELISA+), group II (RIA+/ELISA-), group III (RIA-/ELISA+) and group IV (RIA-/ELISA-). The clinical and genetic characteristics of group I and group III were quite similar in terms of age at diagnosis, male/female ratio, relatively high positive rates for both autoantibody to protein tyrosine phosphatase IA-2 and autoantibody to the cation efflux transporter zinc transporter 8, and human leukocyte antigen genotype. Group II contained just five patients, and was characterized by a younger age at diagnosis, low positive rates for both autoantibody to protein tyrosine phosphatase IA-2 and autoantibody to the cation efflux transporter zinc transporter 8, and a unique human leukocyte antigen genotype. If the positive rates of either autoantibody to protein tyrosine phosphatase IA-2 or autoantibody to the cation efflux transporter zinc transporter 8 or both were added to the GADAb results using RIA, the percentage of autoimmune type 1 diabetes increased from 47.9% to 78.5%. † The membership of the Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes (JSGIT) is listed in the Acknowledgments. Conclusions:The diagnosis of autoimmune childhood-onset Japanese type 1 diabetes increased when GADAb results were obtained using a new ELISA method, compared with a previously utilized RIA method.

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Section: Methodsmentioning

confidence: 59%

Increased diagnosis of autoimmune childhood‐onset Japanese type 1 diabetes using a new glutamic acid decarboxylase antibody enzyme‐linked immunosorbent assay kit, compared with a previously used glutamic acid decarboxylase antibody radioimmunoassay kit

Sugihara

Yokota

Mukai

et al. 2019

J of Diabetes Invest

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“…In the present participants, there were no GADA‐ELISA‐negative participants with HLA‐DRB1*09:01 or HLA‐DQB1*03:03. It might be related to the divergence in HLA we reported and the divergence in the affinity of GADA Kawasaki et al . reported.…”

Section: Discussionmentioning

confidence: 78%

“…In the present participants, there were no GADA-ELISA-negative participants with HLA-DRB1*09:01 or HLA-DQB1*03:03. It might be related to the divergence in HLA we reported and the divergence in the affinity of GADA Kawasaki et al 13 reported. A larger study is required to verify that GAD-antibody-positive people with these HLA genotypes will necessarily become positive on a GADA-ELISA.…”

Section: Discussionmentioning

confidence: 80%

“…Another hypothesis is that the affinity of the GADA that can be detected is different. Kawasaki et al . measured GADA affinity with sera obtained from patients with GADA‐RIA‐positive/GADA‐ELISA‐negative and GADA‐RIA‐negative/GADA‐ELISA‐positive.…”

Section: Discussionmentioning

confidence: 99%

“…Another hypothesis is that the affinity of the GADA that can be detected is different. Kawasaki et al 13 measured GADA affinity with sera obtained from patients with GADA-RIApositive/GADA-ELISA-negative and GADA-RIA-negative/ GADA-ELISA-positive. They reported that GADA-RIA can detect both high-and low-affinity antibodies, but GADA-ELISA can detect only high affinity antibodies.…”

Section: Discussionmentioning

confidence: 99%

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Clinical and genetic characteristics of people with type 1 diabetes who have discrepancies in titers of anti‐glutamic acid decarboxylase antibody measured by radioimmunoassay and enzyme‐linked immunosorbent assay

Takagi

Miura

Hoshina

et al. 2019

J of Diabetes Invest

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Aims/Introduction The aim of the present study was to compare the clinical and genetic characteristics between people with type 1 diabetes who were positive and negative for autoantibodies against glutamic acid decarboxylase (GADA) measured by enzyme‐linked immunosorbent assay (ELISA) with low‐titer GADA measured by radioimmunoassay. Materials and Methods Among Japanese people with type 1 diabetes in whom GADA were measured by both ELISA and radioimmunoassay, those who had low titers of GADA measured by radioimmunoassay (1.5–10 U/mL), regardless of positivity for GADA measured by ELISA, were studied. There were 65 participants with acute‐onset type 1 diabetes and 30 participants with slowly progressive insulin‐dependent diabetes mellitus. Clinical characteristics and human leukocyte antigen types were compared in ELISA‐positive (≥5 U/mL) and ELISA‐negative participants. Endogenous insulin secretion was evaluated by C‐peptide index. Results Among participants with slowly progressive insulin‐dependent diabetes mellitus, postprandial C‐peptide index was significantly higher in ELISA‐negative participants than in ELISA‐positive participants (r = 0.619, P = 0.002). Among 52 participants whose human leukocyte antigen typing was carried out, all of the participants with slowly progressive insulin‐dependent diabetes mellitus who had DRB1*09:01 were positive by GADA‐ELISA (P = 0.021). In acute‐onset type 1 diabetes participants, there were no significant differences for the C‐peptide index and human leukocyte antigen genotypes. Conclusions The difference in the positivity for GADA‐ELISA might reflect cytotoxicity toward pancreatic β‐cells and preservation of endogenous insulin secretion in people with slowly progressive insulin‐dependent diabetes mellitus. We also suggest that the difference in the GADA‐ELISA‐specific epitope depends on the human leukocyte antigen genotype.

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Characteristic phenotype of Chinese patients with adult-onset diabetes who are autoantibody positive by 3-Screen ICA™ ELISA

Wang

Guo²,

Chen³

et al. 2021

Acta Diabetol

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Aims To assess the prevalence of diabetes-associated autoantibodies in Chinese patients recently diagnosed with adult-onset diabetes and to evaluate the potential role of the autoantibody markers for characterization of disease phenotype in the patient population. Methods The study included 1273 recent-onset adult patients with phenotypic type 2 diabetes mellitus (T2DM). Serum samples were tested using the 3-Screen ICA™ ELISA (3-Screen) designed for combined measurement of GADAb and/or IA-2Ab and/or ZnT8Ab. 3-Screen positive samples were then tested for individual diabetes-associated and other organ-specific autoantibodies. Clinical characteristics of patients positive and negative in 3-Screen were analysed. Results Forty-four (3.5%) of the T2DM patients were positive in 3-Screen, and 38 (86%) of these were also positive for at least one of GADAb, IA-2Ab and ZnT8Ab in assays for the individual autoantibodies. 3-Screen positive patients had lower BMI, higher HbA1c, lower fasting insulin levels and lower fasting C-peptide levels compared to 3-Screen negative patients. Analysis using a homeostatic model assessment (HOMA2) indicated that HOMA2-β-cell function was significantly lower for the forty-four 3-Screen positive patients compared to 3-Screen negative patients. Twenty (45%) 3-Screen positive patients were also positive for at least one thyroid autoantibody. Conclusions The 3-Screen ELISA has been used successfully for the first time in China to detect diabetes autoantibodies in patients with phenotypic T2DM. 3-Screen positive patients presented with poorer β cell function.

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Discrepancy of glutamic acid decarboxylase 65 autoantibody results between RSR radioimmunoassay and enzyme‐linked immunosorbent assay in patients with type 1 diabetes is related to autoantibody affinity

Cited by 19 publications

References 16 publications

Increased diagnosis of autoimmune childhood‐onset Japanese type 1 diabetes using a new glutamic acid decarboxylase antibody enzyme‐linked immunosorbent assay kit, compared with a previously used glutamic acid decarboxylase antibody radioimmunoassay kit

Increased diagnosis of autoimmune childhood‐onset Japanese type 1 diabetes using a new glutamic acid decarboxylase antibody enzyme‐linked immunosorbent assay kit, compared with a previously used glutamic acid decarboxylase antibody radioimmunoassay kit

Clinical and genetic characteristics of people with type 1 diabetes who have discrepancies in titers of anti‐glutamic acid decarboxylase antibody measured by radioimmunoassay and enzyme‐linked immunosorbent assay

Characteristic phenotype of Chinese patients with adult-onset diabetes who are autoantibody positive by 3-Screen ICA™ ELISA

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