STANDARDIZATION OF POTENCY TEST METHODS FOR IPV-WHO STUDY

目前需要对灭活脊髓灰质炎病毒疫苗（IPV）效力进行检测

The current tests for inactivated poliovirus vaccine (IPV) potency need standardization between laboratories. A collaborative study has been initiated to assess the suitability of candidate reference materials, assess the suitability of different ELISA methods for D determination, and to assess the variability of a standard ELISA method in different laboratories, using the same reagents and coded samples. The materials included in this study are two commercially prepared candidate reference materials; the primary reference PU78-02 currently used by several laboratories, vaccines from different manufacturers shown to be immunogenic in humans; IPV produced from Sabin strains and vaccines of poor in vivo potency. The study will be divided into two phases. The first phase which has been completed, looked at in vitro assays (the second phase will look at in vivo assays). An ELISA developed at CBER using as detection antibodies monoclonal antibodies specific for D antigen is the candidate standard method. We filled and lyophilized our in-house reagents for distribution to collaborators. Several tests were performed to validate the lyophilized reagents prior to mailing. We prepared a detailed SOP which included the dilution schemes for both practice antigens and test antigens. Collaborators received an ELISA kit containing plates, polyclonal and monoclonal antibodies, monotypic antigens of all three poliovirus types for practice determinations in addition to the SOPs and the CBER results for the practice antigens. Coded test antigens were subsequently mailed. Despite these efforts, the potency results for the monoclonal ELISA assay exhibited unacceptable variability between different laboratories. Furthermore, similar variability was noted in comparing potency determinations based on in-house ELISA determinations. The results of this collaborative study (Wood, D.J., Heath, A.B. and Sawyer, L.A., Biologicals, 1995;23:83-94 have indicated the need for further improvements in potency determinations of IPV.