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

NCT03873974 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

  • Lyme Borreliosis

Interventions

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.

Sponsors & Collaborators

  • Pharmahungary Group

    collaborator INDUSTRY

  • Lyme Diagnostics Ltd.

    lead INDUSTRY

Principal Investigators

  • Bela P. Bozsik, MD · Lyme Diagnostics Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2019-11-25
Completion
2019-12-04

Countries

  • Austria
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Slovakia

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 NCT03873974 on ClinicalTrials.gov