GAD-Ab ELisa Test Kit

INTENDED USE

Detection Kit for Glutamic Acid Decarboxylase Antibody(GAD-Ab)(Enzyme-Linked ImmunoSorbent Assay , ELISA)GAD-Ab EIA kit is used in qualitative tests for Glutamic Acid Decarboxylase Antibody(GAD-Ab)in human serum

SUMMARY AND CLINICAL SIGNIFICANCE

Glutamate decarboxylase (GAD) is a rate-limiting enzyme that converts glutamate into an inhibitory neurotransmitter gamma-aminobutyric acid (GABA), GAD exists in islet β cells, and is also synthesized and secreted by GABA. Glutamate decarboxylase antibody (GADA) is an immune marker for the early stage of type 1 diabetes mellitus and is also used as a therapeutic indicator for the treatment of type 1 diabetes mellitus. The prevalence of GADA in patients with type 1 diabetes mellitus with Graves disease was significantly higher than that in patients with type 1 diabetes without Graves disease. GAD levels in patients with Graves were significantly higher, and the incidence of GADA in non-diabetic patients did not always predict type 1 diabetes.

PRINCIPLE

GAD-Ab EIA Kit will advance the recombinant human Glutamic Acid Decarboxylase was coated on the reaction plate, is used to capture the GAD-Ab in the sample, washing out extraneous material, then adding horseradish peroxidase (HRP) labeled mouse anti human IgG antibody. Finally, the formation of solid phase labeled anti-human

IgG complex, plus TMB color system after the role of color, the sample can be detected in human serum insulin antibody in the presence of the determination.

PRECAUTION FOR USERS

• Handling should preclude any pipetting by mouth.
• Use only pipettes with disposable tips for each specimen.
• Do not mix materials from different master lots. Do not use kit components beyond the expiration date. All materials should be brought to room temperature before use.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world