Preparation and characterization of a human serum matrix suitable for quality control or reference materials

Area of Science:

• Clinical Chemistry
• Biochemistry
• Materials Science

Background:

• Quality control materials are essential for accurate clinical laboratory testing.
• Existing serum-based matrices may lack long-term stability or contain undesirable protein components.
• Development of a robust and reliable serum matrix is needed for consistent diagnostic performance.

Purpose of the Study:

• To describe the preparation of a novel human serum-based matrix.
• To assess the stability and optical clarity of the prepared matrix.
• To characterize the protein composition of the matrix for quality assurance.

Main Methods:

• Human blood was processed to remove cells, fibrin, and lipoproteins.
• The resulting serum matrix was stored at -70°C for up to 14 months.
• Polyacrylamide gel electrophoresis (PAGE) was used to analyze protein composition.

Main Results:

• The prepared serum matrix remained clear and stable after prolonged frozen storage.
• Storage at 4°C and -20°C did not compromise optical clarity, despite minor changes in some constituents.
• PAGE analysis revealed no abnormal protein bands, unlike some commercial alternatives.

Conclusions:

• A stable, optically clear human serum matrix suitable for long-term control materials has been successfully prepared.
• The reduction of lipoproteins contributes to the matrix's clarity and stability.
• This matrix serves as a reliable component for quality control in chemical pathology.