NCT03873974

Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis

Multicentre Clinical Trial to Assess the Performance of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis From Blood Samples of Subjects Who Are Either Pharmacotherapy-naive or Treatment-experienced and Their Physician Indicates Drug Therapy for Lyme Borreliosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Lyme Diagnostics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.

Detailed description

The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System. * The sensitivity of the DualDur in Vitro Diagnostic System will be examined in subjects whose physician indicates drug therapy for Lyme borreliosis (positive arm). * The specificity of the DualDur in Vitro Diagnostic System will be examined in healthy volunteers declared Lyme borreliosis negative by their physician and all the standard laboratory tests prove that they are free of Lyme borreliosis (negative arm). The diagnostic system developed by Lyme Diagnostics Ltd. is planned for application in the diagnosis during the entire life cycle of Lyme borreliosis.

Conditions

• Lyme Borreliosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DualDur dark-field microscopic test	Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Manual evaluation.
DIAGNOSTIC_TEST	DualDur dark-field automatic microscopic test	Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Software evaluation.
DIAGNOSTIC_TEST	Western blot IgM and IgG	Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
DIAGNOSTIC_TEST	Bózsik Western blot IgM and IgG	Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
DIAGNOSTIC_TEST	enzyme-linked immunosorbent assay (ELISA) IgM and IgG	Standard ELISA test for Lyme borreliosis.
DIAGNOSTIC_TEST	DualDur Polymerase chain reaction	DualDur PCR test for Lyme borreliosis.

Timeline

• Start date: 2019-07-02
• Primary completion: 2019-11-25
• Completion: 2019-12-04
• First posted: 2019-03-14
• Last updated: 2020-03-02

Locations

8 sites across 6 countries: Austria, Czechia, Germany, Hungary, Poland, Slovakia