Glutamic Acid Decarboxylase Autoantibody (GADA) ELISA Kit
  • Glutamic Acid Decarboxylase Autoantibody (GADA) ELISA Kit

    ★ Download Datasheet PDF ★

     

    Typical results

    (Example only, not for calculation of actual results)

     

    Calibrator*

    Concentration (IU/ml)

    OD450

    OD405

    1

    2000

    7.86

    2.3425

    2

    250

    5.24

    1.56

    3

    120

    3.732

    1.0865

    4

    35

    1.445

    0.439

    5

    18

    0.794

    0.2565

    6

    10

    0.4785

    0.168

    7

    5

    0.276

    0.1125

    Negative Control

    0

    0.096

    0.0655

    Positive

    Control

    15.18

    0.746

    0.235

     

     *Calibrator standardised against NIBSC 97/550.

     

    Cut-off Value

     

    Cut off

    IU/ml

    Negative

    < 5 IU/ml

    Positive

    ≧ 5 IU/ml


    *This cut off has been validated at ImmunoDiagnostics. However, we recommend each laboratory establish its own reference ranges of GADA levels to distinguish healthy and pathological subjects, as well as include its own internal control samples in the assay.

     

    • INTRODUCTION

      Glutamic acid decarboxylase autoantibodies (GADA) are found in 70% to 80% of individuals with new-onset type 1 diabetes, making it the most frequent autoantibody in autoimmune diabetes.

      GADA can be detected in serum for many years post diagnosis, and high concentrations of GADA have been considered as a marker of faster β-cell exhaustion in these patients.

      Furthermore, GADA in non-diabetic individuals predicts the later development of type 1 diabetes1.

      Besides autoimmune diabetes, GADA also exists in Stiff Man Syndrome, autoimmune poly-endocrinopathies, and some of Grave’s Disease patients2.

    • ASSAY CHARACTERISTICS

      Clinical Evaluation

      Sensitivity

       92.5% (n=80)

      Specificity

      95% (n=150)

       

      Inter-Assay Precision

      Sample

      IU/ml (n=20)

      CV

      1

      120

      5.75%

      2

      18

      6.66%

      3

      5

      5.26%

       

      Intra-Assay Precision

      Sample

      IU/ml (n=20)

      CV

      1

      120

      6.61%

      2

      18

      4.63%

      3

      5

      5.65%


      Sample Type: Serum 

      Storage : 4°C

    • References:

      1.Liu B, et al. Past, present and future of latent autoimmune diabetes in adults. Diabetes Metab Res Rev. 2019 Jul 18:e3205. 

      2.Björk E, et al. GAD autoantibodies in IDDM, stiff-man syndrome, and autoimmune polyendocrine syndrome type I recognize different epitopes. Diabetes. 1994 Jan;43(1):161-5.

    • DATA SHEET

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