Model selection methodology for inter-laboratory standardisation of antibody titres

Area of Science:

• Immunology
• Epidemiology
• Public Health

Background:

• Comparing serological results for vaccine-preventable diseases across European countries is challenging due to laboratory and assay variability.
• Standardized serological data is crucial for accurate epidemiological assessments and public health policy in Europe.

Purpose of the Study:

• To establish a standardized method for comparing serological results of vaccine-preventable diseases across Europe.
• To develop and validate an algorithm for creating standardization equations to adjust for laboratory and assay differences.

Main Methods:

• Participant laboratories tested a standardization panel for each disease.
• Results were plotted against a reference center to derive standardization equations.
• A robust algorithm was developed to account for outliers, censored data, and model selection.

Main Results:

• Standardization equations were successfully generated to adjust for laboratory and assay variations.
• The algorithm proved robust across various assays and diseases.
• Conversion of country-specific serum bank results to a common unitage was achieved where equations explained sufficient variability.

Conclusions:

• The developed algorithm provides a robust method for standardizing serological results across different laboratories and assays.
• This standardization enables reliable international comparisons of vaccine-preventable disease seroprevalence in Europe.
• The ESEN2 approach facilitates more accurate public health surveillance and policy-making.