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Development of a certified reference material for anti-β2-glycoprotein I IgG - commutability studies
Evanthia Monogioudi1, Gustavo Martos1,2, Joanna Sheldon3
1European Commission - Joint Research Centre (JRC), Geel, Belgium.
Clinical Chemistry and Laboratory Medicine
|October 1, 2020
Summary
A new reference material for immunoglobulin G antibodies against β2-glycoprotein I was developed. This material is stable, homogeneous, and commutable for most assays, aiding in antiphospholipid syndrome diagnosis.
Area of Science:
- Clinical Chemistry
- Immunology
- Biotechnology
Background:
- Immunoglobulin G antibodies against β2-glycoprotein I are crucial biomarkers for antiphospholipid syndrome, linked to thrombosis and pregnancy complications.
- Current immunoassays for these antibodies exhibit significant variability, partly due to the absence of a standardized reference material.
- Accurate measurement is essential for diagnosis, monitoring, and risk assessment in patients with antiphospholipid syndrome.
Purpose of the Study:
- To describe the development of a certified reference material for immunoglobulin G antibodies against β2-glycoprotein I.
- To establish the material's commutability, homogeneity, stability, and optimal reconstitution conditions for reliable diagnostic use.
Main Methods:
- Development and characterization of a reference material for anti-β2-glycoprotein I immunoglobulin G antibodies.
- Analysis of 69 clinical samples from antiphospholipid syndrome patients using commercial enzyme-linked immunosorbent assays (ELISA).
- Evaluation of material processing, dilution impact, reconstitution, homogeneity, and stability.
Main Results:
- The developed reference material can be safely freeze-dried, with specific reconstitution instructions provided.
- Commutability studies demonstrated similar analytical responses to clinical samples upon dilution, though assay-specific correlations varied.
- The reference material proved to be homogeneous, stable, and commutable for the majority of tested immunoassays.
Conclusions:
- The newly developed reference material is suitable for use in diagnostic assays for immunoglobulin G antibodies against β2-glycoprotein I.
- This reference material addresses the variability in current immunoassays, supporting more accurate diagnosis and monitoring of antiphospholipid syndrome.
- Adherence to reconstitution protocols is critical for achieving reliable results with the reference material.
