NCT05041595

Lyme Disease Diagnostic Assay - Collection of Whole Blood

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: DiaSorin Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Lyme Disease
• Healthy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lyme diagnostic assay	Serological and immunoresponse assay

Timeline

• Start date: 2021-05-03
• Primary completion: 2023-12-30
• Completion: 2024-12-31
• First posted: 2021-09-13
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study