Autoimmune Diseases
Autoimmune diseases (ADs) is a condition in which the immune system mistakenly attacks the body’s own tissues/cells. Over 80 types of ADs have been identified in humans and ADs can occur in any part of the body (see the left diagram below). The incidence of ADs is increasing rapidly worldwide in recent years due to environmental changes. ADs are now the 4th largest cause of disability in women and the 8th leading cause of death for women between ages 15-64.
Current in vitro diagnostics (IVD) of ADs mainly depends on the detection of circulating auto-antibodies specifically associated with certain ADs (see the right diagram below). By generating autoantigen-based immunoassays, corresponding autoantibodies can be determined in the blood stream of patients via the autoantigen-autoantibody interaction.

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:
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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.
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Low throughput for screening for multiple ADs whereas many ADs are inter-related.
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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:
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>25 high-quality recombinant autoantigens using insect and mammalian cell expression systems;
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5 highly sensitive and specific ELISA kits;
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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.
Product List
Ready-to-use Immunoblot ANA Strips
High-sensitive ELISA Kits
Cat No. Datasheet Product Name Assay Range
31A040 Human Anti-dsDNA ELISA (IgG) 20-600 IU/ml
31A030 Human Anti-Histones ELISA (IgG) 10-500 RU/ml
31840 Human GAD Autoantibody ELISA Kit 5-2000 IU/ml
31330 Human Neutrophile Elastase ELISA Kit 0.156-10 ng/ml
31300 Human Proteinase 3 ELISA Kit 0.156-10 ng/ml
Validated High-quality Autoantigens
Autoantigens of Systemic Lupus Erythematosus
Cat No. Datasheet Product Name Species Expression System
41540 SmD1 Human Sf9 insect cells
41550 SmD3 Human Sf9 insect cells
41530 SmB/B' Human Sf9 insect cells
41570 PCNA Human Sf9 insect cells
41A035 Native Histones Human Mammalian cells
41560 RPLP0 (P0) Human E.coli cells
41A040 dsDNA Bovine
41810 Histone H2A Human E.coli cells
41820 Histone H2B Human E.coli cells
41830 Histone H3 Human E.coli cells
Autoantigens of Mixed Connective Tissue Disease
Cat No. Datasheet Product Name Species Expression System
41510 U1snRNP A Human Sf9 insect cells
41520 U1snRNP C Human Sf9 insect cells
41500 U1snRNP 68/70 Human Sf9 insect cells
Autoantigens of Sjøgrens Syndrome
Autoantigens of Polymyositis / Dermatomyositis
Cat No. Datasheet Product Name Species Expression System
41470 Jo1 Human Sf9 insect cells
41480 PL7 Human Sf9 insect cells
41490 PL12 Human Sf9 insect cells
41A180 Ku70/80 Human Sf9 insect cells
41A190 Mi2 beta Human Sf9 insect cells
41A242 SRP Human Sf9 insect cells
41A252 EJ Human Sf9 insect cells
Autoantigens of Systemic Sclerosis / CREST Syndrome
Autoantigens of Autoimmune Diabetes
Cat No. Datasheet Product Name Species Expression System
41842 GAD65 (full-length) Human Sf9 insect cells
41846 GAD65 (1-45aa truncated) Human Sf9 insect cells
41847 GAD65 (1-95aa truncated) Human Sf9 insect cells
41850 IA2 Human E.coli cells
Autoantigens of Autoimmune Hepatitis (AIH) and Primary Biliary Cholangitis (PBC)
Cat No. Datasheet Product Name Species Expression System
41A052 LC 1 Human Sf9 insect cells
41A062 BCOADC-E2 Human Sf9 insect cells
41A072 OGDC-E2 Human Sf9 insect cells
41A082 PDC-E2 Human Sf9 insect cells
41A162 SP100 Human Sf9 insect cells
41A152 SLA/LP Human Sf9 insect cells
41A262 LKM-1 Human Sf9 insect cells
41A272 PML Human Sf9 insect cells
41A280 Gp210 Human E.coli cells