Multiple detection methods, such as ELISA, immunofluorescence test, and radio-immunoassay, have been applied for the diagnosis of ADs. However, there are several major challenges remained:

• The sensitivity and accuracy of the majority of existing diagnostic kits is very low, as the auto-antigens used for these assays are mainly produced in E. coli cells, therefore do not preserve proper epitopes for efficient recognition of autoantibodies.

• Low throughput for screening for multiple ADs whereas many ADs are inter-related.

• Detection of autoantibodies can not provide pathogenic insights.                                                                                           

ImmunoDiagnostics has developed a comprehensive platform ranging from the discovery of novel autoantibodies and biomarkers for ADs, production of high-quality recombinant autoantigens with structures resembling native protein in vivo, to development and clinical validation of highly sensitive and specific immunoassays for autoantibodies and new biomarkers. Our unique tech platform has significantly increased the detection rate and specificity for multiple major ADs.                                                        

By far, we have developed a series of ready-to-use diagnostic kits and high-quality raw materials for ADs:

• >25 high-quality recombinant autoantigens using insect and mammalian cell expression systems;

• 5 highly sensitive and specific ELISA kits;

• 6 types of membrane-based test strips for 7 major ADs.                                                                                                   

All the kits and raw materials have been validated in >300 clinical samples and been proven to show excellent batch-to-batch repeatability, specificity, and accuracy.