Objective To verify the feasibility of using domestic microplate and domestic cell wall polysaccharides(CWPS)to replace currently imported enzyme plates(Greiner 655080)and the CWPS of Statens Serum Institut(SSI)for detecting anti-cap-sular polysaccharide IgG antibodies in human serum of pneumo-coccal vaccines.Methods Domestic microplate and CWPS were used separately to test anti-capsular polysaccharide IgG an-tibodies of 24 pneumococcal serotypes by PnPS ELISA method,then analyze the results with currently used CWPS of SSI and Greiner 655080 microplate as the control group.Results ①The content of anti-capsular polysaccharide IgG antibodies of 24 serotypes was completely consistent with which tested by imported microplate,and the lin's concordance correlation coefficient(rc)was 0.990 3;the consistency was strong when testing the same 20 laboratory quality-control sera,with rc of 0.958 0;the lower limit of detection(LLQ)of the 24 serotypes was between 0.008 and 0.072 μg/mL,while the LLQ of currently used microplate was 0.010-0.079 μg/mL.② The bio-chemical test results and 1H Nuclear Magnetic Resonance Spectroscopy(NMR)of domestic CWPS were basically consist-ent with the current SSI CWPS;the test results of quality-control serum 09CS were completely consistent,the rc was 0.999 0.The test results of 10 pairs of sera(before and after immunization)detected by SSI CWPS and domestic CWPS,the consistency was strong,the rc of pre-immunization serum was 0.953 0,and the rc of post-immunization serum was 0.972 0.Conclusion Domestic CWPS and ELISA plates can replace imported ELISA plates and SSI's CWPS for detecting anti-capsular polysaccharide IgG antibodies in human serum of pneumococcal vaccines.
Streptococcus pneumoniaCell wall polysaccharides96 well microplateELISAValidation
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