The Research And Development Of The ELISA Kit Of IgG Antibody To Human Cytomegalovirus

Human cytomegalovirus(HCMV),also known as cell inclusion body virus,is a double helix DNA virus belonging to the family of herpesvirus.It is called cytomegalovirus,because the infected cells are swollen and have a hμge nuclear inclusion body.HCMV infection mainly occurs throμgh contact,blood transfusion,intrauterine and birth canal,etc.Infection is more common in fetuses,newborns,pregnant women,etc.Infection of pregnant women may lead to the deformity of neonatal antecedents.When the body’s immune deficiency or immune system is in a state of suppression,it is highly susceptible to HCMV infection,such as organ transplantation after receiving immunosuppression therapy,malignant tumor chemotherapy,AIDS patients,etc.These patients,once infected,often lead to a higher case fatality rate and serious disease.Cytomegalovirus IgG antibody detection system is established by evaluating coating,closing,selecting second antibody,selecting TMB,selecting coats wells,selecting add samples,selecting incubating time,is used enzyme-linked immune indirect method.The conformant rate of negative reference products,positive reference products,repeatability,inter-batch difference,detection limit,analysis specificity and other technical indicators of the continuous production of three batches of kits were evaluated,and 1050 samples were compared for experimental study,and the resμLts were tested by Kappa test,X~2 test and correlation analysis.It was studied of the stability of kit,including real-time stability,high temperature accelerated failure stability,bottle opening stability,transport stability and repeated freeze-thaw stability,and the stability of the kit was comprehensively evaluated according to the resμLts of its accuracy,specificity,repeatability and detection limit.The conformant rate of negative reference products,positive reference products,repeatability,inter-batch difference,detection limit,analysis specificity and other technical indicators of the continuous production of three batches of kits were evaluated,and 1050samples were compared for experimental study,and the resμLts were tested by Kappa test,X~2test and correlation analysis.It was studied of the stability of kit,including real-time stability,high temperature accelerated failure stability,bottle opening stability,transport stability and repeated freeze-thaw stability,and the stability of the kit was comprehensively evaluated according to the resμLts of its accuracy,specificity,repeatability and detection limit.A detection kit for IgG antibody to cytomegalovirus was successfμLly developed,preparing the license of in vitro diagnostic kit,and was suitable for the clinical monitoring,diagnosis and prognosis of plaque.