Scientific Publications by FDA Staff

Clin Vaccine Immunol 2017 Feb 6;24(2):e00457-16

Assignment of Opsonic Values to Pneumococcal Reference Serum 007sp for use in Opsonophagocytic Assays for 13 Serotypes.

Burton RL, Antonello J, Cooper D, Goldblatt D, Kim KH, Plikaytis BD, Roalfe L, Wauters D, Williams F, Xie GL, Nahm MH, Akkoyunlu M

Opsonophagocytic assays (OPAs) are routinely used for assessing the immunogenicity of pneumococcal vaccines, with OPA data often utilized for licensure of new vaccine formulations. However, no reference serum for pneumococcal OPAs is available, making evaluation of data among different laboratories difficult. This international collaboration was initiated to: 1) assign consensus opsonic indexes (OIs) to Pneumococcal Reference Serum Lot 007sp ("007sp") and a panel of calibration sera; and 2) determine if normalization with 007sp decreases the OPA variability among laboratories.To meet these goals, six participating laboratories tested a panel of sera in five runs for 13 serotypes. For each serum, consensus OIs were obtained using a mixed effects ANOVA model. For the calibration sera, normalized consensus values were also determined based on 007sp.For each serotype, the overall reduction in inter-laboratory variability was calculated by comparing the coefficients of variation of the unadjusted and the normalized values. Normalization of the results substantially reduced the inter-laboratory variability, ranging from a 15% reduction in variability for serotype 9V to 64% for serotype 7F. Normalization also increased the proportion of data within 2-fold of the consensus value from approximately 70% (average of all serotypes) to >90%.Based on the data obtained in this study, Pneumococcal Reference Standard Lot 007sp will likely be a useful reagent for normalizing pneumococcal OPA results from different laboratories. The data also support the use of the 16 FDA OPA calibration sera as part of the initial evaluation of new assays or periodic assessment of established assays.