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Clinical validation of islet autoantibody measurement in self-collected dried blood spot specimens

Primary Objective

Can ADAP assay accurately detect GADA, IA2A, IAA and ZnT8A in self-collected capillary dried blood spot specimens.

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Description

Accessible testing of islet autoantibody may improve the clinical management of type 1 diabetes. We propose to validate the detection of islet autoantibodies for type 1 diabetes in self-collected capillary dried blood spot samples. Capillary blood spots do not require a visit to the doctor office and can be done without a phlebotomist, thereby lowering the testing barrier compared to venous blood draws. The assay performances will be compared to matching serum samples collected from the same individuals tested with FDA-cleared devices. The successful validation of the sample collection kit and assay may lead to the first regulatory-cleared assays for islet autoantibodies in self-collected sample types.

Details
Age
All Ages
Eligibility
Aged over 1 year No first, second or third degree relatives with T1DWilling to provide informed consent and adhere to the study protocol Willing to allow collection of venous blood tubes for processing to serum and whole blood. Has not previously received any form of insulin therapy Have been diagnosed with type 2 diabetes, celiac diseases, thyroid diseases (e.g. Graves disease, Hashimoto diseases), Addison disease, pancreatic cancer, neurological diseases (e.g. stiff person syndromes, limbic encephalitis, epilepsy, cerebellar ataxia) or other autoimmune, metabolic, hormone or allergy diseases
Locations

Barbara Davis Center

Principal Investigator
Photograph of Kimber Simmons

Kimber Simmons

Study ID

Protocol Number: 23-2561

Categories

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