The invention relates to the technical fields of
gene engineering,
antibody engineering and immunodiagnosis. The invention provides a recombinant humanized anti-Cpn
IgM monoclonal antibody. The
monoclonal antibody comprises a light chain variable region and a
heavy chain variable region, the light chain variable region comprises three complementary determining regions CDR1, CDR2 and CDR3, and the
amino acid sequences of the three complementary determining regions are respectively shown as SEQ ID NO.3, SEQ ID NO.4 and SEQ ID NO.5; the
heavy chain variable region comprises three complementary determining regions CDR1, CDR2 and CDR3, and the
amino acid sequences of the three complementary determining regions are shown as SEQ ID NO.6, SEQ ID NO.7 and SEQ ID NO.8 respectively. The invention also provides a method for preparing the
monoclonal antibody. The recombinant humanized anti-Cpn
IgM monoclonal antibody provided by the invention is expressed in mammalian cells by utilizing a
gene recombination technology, has the characteristics of high purity, small batch difference and the like, and can be applied to a Cpn
IgM antibody detection kit as a
quality control product; as a
quality control product, the recombinant humanized anti-Cpn
IgM monoclonal antibody has the advantages of high sensitivity, high safety, inter-batch stability and the like.