Validation and comprehensive analysis ofStreptococcus pneumoniae IgG WHOenzyme linked immunosorbent assay in anIndian reference laboratory: supplementary data

Monitoring serotype-specific IgG levels against pneumococci is crucial for assessing immunity, vaccine
efficacy, and evaluating vaccination programs. The WHO ELISA for pneumococci is a standardized assay
ensuring consistency in testing and comparability of results across laboratories. It involves a rigorous
testing process to confirm accurate, precise, and reliable detection of antibodies. We validated the
protocol for 13 pneumococcal serotypes by assessing its specificity, reproducibility (coefficient of variation
≤15%), repeatability (coefficient of variation ≤20%) , accuracy, lower limit of quantification, stability,
and robustness. We found these parameters were within acceptable ranges and showed excellent
performance. Our findings imply that the method employed is appropriate for evaluating 13 valent
pneumococcal conjugate vaccine which is introduced in the national immunization program by comparing
pre-and post-vaccination IgG response.