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Lyme Disease Diagnostic Assay - Collection of Whole Blood

Healthy Clinical Trial

Official title:
Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.

Clinical Trial Summary

The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease. In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.

Clinical Trial Description

Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05041595
Study type Observational
Source DiaSorin Inc.
Contact
Status Enrolling by invitation
Phase
Start date May 3, 2021
Completion date December 31, 2024
View Details
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