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The GalD Assay

Standardized Lectin-Based ELISA
Measurement of Serum Galactose-Deficient IgA1

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View GalD Assay Package Insert

Research Use Only

For the first time, The GalD Assay provides a robust means to measure serum galactose-deficient IgA1 (Gd-IgA1) levels across cohorts and centers, and in serial samples. The assay is based on a lectin binding to any of the accessible galactose-deficient sites of multiple disease-causing forms of Gd-IgA1 [4, 6]. Lectin-based measurements of serum Gd-IgA1 [7] served as the basis for the 4-Hit hypothesis of IgAN [8] and revealed multiple disease-associated forms of Gd-IgA1 [4]. The GalD Assay provides the most comprehensive assessment of Gd-IgA1 relevant to IgAN pathogenesis and enables any group to integrate quantification of this proven serum biomarker into their IgAN studies.

  • Galactose-deficient IgA1 (Gd-IgA1) plays the central role in development of IgAN [1, 2].
  • Serum Gd-IgA1 levels measured with
    lectin-based ELISA have prognostic value for long-term kidney outcomes in IgAN [3].
  • Lectin-based measurements detect the wide range of glycoforms of Gd-IgA1 [4,5].
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Additional wash buffers are available for purchase, including W1 and RB/W2 Add. reagents.

Analysis of serum samples from 3 distinct cohorts with The GalD Assay showed differences between the median serum Gd-IgA1 levels of healthy controls and patients with IgAN. More than half of IgAN patients had GalD values >75th percentile of healthy controls.

References
1. Suzuki H, et al. J Clin Invest 2009
2. Moldoveanu Z, et al. J Autoimmun 2021
3. Zhao N, et al. Kidney Int 2012
4. Craine, EP, et al. J Am Soc Nephrol 2020
5. Takahashi K, et al. Mol Cell Proteomics 2010
6. Ohyama Y, et al. iScience 2022
7. Moldoveanu Z, et al. Kidney Int 2007
8. Suzuki H, et al. J Am Soc Nephrol 2011

Potential Uses of The GalD Assay

The GalD Assay provides opportunity for a wide range of applications to better understand IgAN patients collectively and at the individual level.

Compare IgAN cohorts from various studies:

  • Across academic cohorts
  • Across clinical trials
  • Enable longitudinal analysis

Risk-stratify patients to:

  • Establish risk thresholds of serum Gd-IgA1 levels
  • Identify serum Gd-IgA1 target levels
  • Prioritize for undergoing kidney biopsy

Monitoring IgAN patients individually over time:

  • Response to disease-modifying treatment
  • After discontinuing treatment
  • Identify patients at high risk of recurrent disease after kidney transplantation