A lyophilized hemoglobin control prepared from stroma-free hemolysates

Area of Science:

• Hematology
• Biochemistry
• Analytical Chemistry

Background:

• Accurate hemoglobin measurement is crucial for diagnosing and monitoring various medical conditions.
• Existing hemoglobin controls may lack long-term stability or require complex preparation.
• Development of a stable, easy-to-use hemoglobin control is needed for clinical laboratories.

Purpose of the Study:

• To develop and characterize a stable lyophilized hemoglobin control derived from human erythrocytes.
• To assess the long-term stability and reproducibility of the prepared control.
• To evaluate the impact of additives on the control's reconstitution and stability.

Main Methods:

• Human erythrocytes were processed to remove stroma using calcium and Ficoll.
• Polyhydroxy compounds were added to enhance reconstitution and stability.
• Lyophilized product stability was assessed through real-time usage and accelerated aging studies.
• Reproducibility was evaluated after reconstitution and refrigeration.

Main Results:

• A stable lyophilized hemoglobin control was successfully prepared.
• The control demonstrated stability for one year in a service laboratory setting.
• Accelerated aging predicted up to two years of stability, with a 6% annual increase in methemoglobin.
• Reconstituted control yielded reproducible values for at least five days under refrigeration.

Conclusions:

• The developed lyophilized hemoglobin control offers a stable and reliable option for laboratory use.
• The preparation method, utilizing stroma removal and polyhydroxy compounds, enhances product longevity.
• This control provides consistent and reproducible results, supporting accurate hemoglobin analysis.