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Lyme Disease Diagnostic Assay - Collection of Whole Blood

NCT05041595 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Lyme Disease
  • Healthy

Interventions

DIAGNOSTIC_TEST

Lyme diagnostic assay

Serological and immunoresponse assay

Sponsors & Collaborators

  • DiaSorin Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2023-12-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041595 on ClinicalTrials.gov