Validation of the ELISA quantitative determination method for the 1,3,5 and 7F pneumococcal capsular polysaccharide antibody IgG
LI Hong
LI Ya-nan
LI Mao-guang
CHEN Qiong
WANG Chun-e
CHEN Cui-ping
YE Qiang
Abstract：Objective:To validate the quantitative ELISA method for the serotype specific IgG antibody concentrations of 1,3,5 and 7F.Methods:Pneumococcal ELISA calibration sera (panel B 12/278)were assayed with pneumococcal international reference serum (007sp) for the linear range,R2,detection limit and accuracy.Another 3 serum quality control samples were tested constantly with 007sp to get the precision,and the inhibition assay was tested with one serum quality control sample with different polysaccharide concentration.Results:The linear range,R2 and detection limit reached the acceptable criteria,andthe accuracy,the precision,and the specificity are satisfactory.Conclusion:Validation results showed that the ELISA method was appropriate for the determination of penumococcal clinical serum antibody concentrations.
Keywords：Strepcoccus pneumoniaclinical seraantibodyELISAvalidation
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1551-1555 )