The D-antigen ELISA is the commonly accepted test for release of inactivated poliovirus containing vaccines. However, this test has a few drawbacks regarding the many variations in the method to quantify the D-unit. The result may depend on method and reagents used which makes standardization of inactivated polio vaccines, based on D-units, to a real challenge. This chapter describes a surface plasmon resonance based method to quantify D-units. The advantage of the calibrated D-antigen assay is the decrease in test variations because no labels, [no incubation times] and no washing steps are necessary. For standardization of both IPV and Sabin IPV, the calibration free concentration analysis could be an improvement as compared to ELISA or other SPR methods because this method combines quantity (particle concentration) and quality (antigenicity) in one assay.
【저자키워드】 surface plasmon resonance, Polio vaccine, IPV, D-antigen ELISA, Sabin, Calibrated D-ag assay, Calibration free concentration assay,