Time to address quality control processes applied to antibody testing for infectious diseases

Area of Science:

• Clinical diagnostics
• Immunology
• Laboratory quality management

Background:

• Infectious disease serology assays are transitioning to automated platforms, adopting quality control (QC) methods from clinical chemistry.
• Significant differences exist between serology and clinical chemistry testing that impact QC strategy.
• Current QC practices may not adequately address the unique characteristics of infectious disease serology.

Purpose of the Study:

• To highlight the discrepancies between clinical chemistry and infectious disease serology testing.
• To evaluate the suitability of traditional clinical chemistry QC methods for serology.
• To provide recommendations for appropriate QC in infectious disease serology.

Main Methods:

• Comparative analysis of assay principles in clinical chemistry and infectious disease serology.
• Review of regulatory requirements and international standards (ISO 15189, WHO) for QC.
• Discussion of lot-to-lot variation in serology assays and control materials.

Main Results:

• Infectious disease serology measures binding intensity, not antibody quantity, and exhibits inherent lot-to-lot variation.
• Clinical chemistry QC methods, assuming stable analytes, are often unsuitable for serology.
• Manufacturer controls are often mandatory, but third-party controls with minimal variation are recommended.

Conclusions:

• Standard clinical chemistry QC approaches are inappropriate for infectious disease serology.
• Robust QC for serology requires controls designed to manage lot-to-lot variation and detect significant assay deviations.
• Implementing tailored QC strategies is crucial for ensuring the reliability of infectious disease diagnostic tests.