NCT02741609

A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Advanced Laboratory Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease. This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.

Conditions

• Lyme Disease

Interventions

Type	Name	Description
DEVICE	Borrelia Diagnostic Test	The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-04-18
• Last updated: 2018-01-17

Locations

16 sites across 1 country: United States