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, vaccineefficacy, and evaluating vaccination programs. The WHO ELISA for pneumococci is a standardized assayensuring consistency in testing and comparability of results across laboratories. It involves a rigoroustesting process to confirm accurate, precise, and reliable detection of antibodies. We validated theprotocol 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 excellentperformance. Our findings imply that the method employed is appropriate for evaluating 13 valentpneumococcal conjugate vaccine which is introduced in the national immunization program by comparingpre-and post-vaccination IgG response.

监测肺炎链球菌血清型特异性免疫球蛋白G（IgG）水平，对于评估机体免疫力、疫苗效力以及优化疫苗接种计划均具有关键意义。世界卫生组织（WHO）针对肺炎链球菌的ELISA检测方法属于标准化检测方案，可保障各实验室间检测操作的一致性与检测结果的可比性。该方法采用严格的检测流程，以确保抗体检测的准确性、精密度与可靠性。本研究针对13种肺炎链球菌血清型，通过评估该方法的特异性、重现性（变异系数≤15%）、重复性（变异系数≤20%）、准确性、定量下限、稳定性以及稳健性，对其检测方案进行了验证。研究结果显示，上述各项参数均处于可接受范围内，且检测性能优异。本研究结果表明，所采用的检测方法可通过比较疫苗接种前后的IgG抗体应答水平，适用于评估纳入国家免疫规划的13价肺炎球菌结合疫苗（13-valent pneumococcal conjugate vaccine）。