Acceptance of values assigned to serum-based calibration materials

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Chemistry

Background:

• Accurate calibration is crucial for reliable clinical laboratory results.
• Assigned values for serum-based calibration materials are critical for accurate patient testing.
• Variability in assigned values can impact diagnostic accuracy.

Purpose of the Study:

• To investigate the acceptance and modification of assigned values for serum calibration materials by laboratories.
• To identify reasons and patterns associated with changes made to assigned values.
• To provide detailed analysis for specific analytes and instrument platforms.

Main Methods:

• A questionnaire was distributed to laboratories across the UK and Ireland.
• Data collected included the acceptance or rejection of assigned values for 14 analytes.
• Analysis focused on the reasons, magnitude, and direction of value changes, and their relation to manufacturers and batches.

Main Results:

• Overall, 33% of assigned values for serum calibration materials were modified by laboratory users.
• Unidirectional changes were often linked to specific batches and manufacturers.
• Detailed findings are presented for protein, sodium, bicarbonate, and bilirubin on specific analytical platforms.

Conclusions:

• Significant user-driven adjustments to assigned calibration material values occur in clinical laboratories.
• Understanding the drivers of these changes is essential for improving calibration material quality and laboratory practice.
• Manufacturer and batch-specific issues contribute to the need for value modifications.