Towards standardization of specific protein assays

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Biochemistry

Background:

• Standardization of serum protein measurements is crucial for accurate clinical diagnostics.
• Previous methods lacked consistent inter-laboratory agreement, impacting patient care.
• International efforts have led to new reference materials for protein quantification.

Purpose of the Study:

• To introduce and advocate for the adoption of new international reference preparations for human serum proteins.
• To highlight the benefits of standardization in improving the transferability of laboratory results.
• To inform clinical laboratories and physicians about upcoming changes in protein reference ranges.

Main Methods:

• Introduction of Certified Reference Material 470 (CRM 470) in Europe and Reference Preparation for Proteins in Human Serum (RPPHS) in the United States.
• Recommendation for universal laboratory adoption by the International Federation of Clinical Chemistry.
• Implementation of new protein calibrators in external quality control programs.

Main Results:

• Expected improvement in agreement for key proteins (IgA, IgG, CRP) in quality control.
• Significant modifications observed in reference ranges for several serum proteins (e.g., alpha 1-antitrypsin, haptoglobin, transferrin, C3, IgM).
• Facilitation of enhanced standardization and result comparability across different laboratories.

Conclusions:

• The new reference materials (CRM 470, RPPHS) are essential for standardizing serum protein concentrations.
• Adoption of these materials will significantly improve the reliability and transferability of clinical laboratory data.
• Clinical chemists must communicate updated reference ranges to physicians to ensure appropriate clinical interpretation.