Lyme Borreliosis Clinical Trial
Official title:
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
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 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.
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