400
Participants
Start Date
July 2, 2019
Primary Completion Date
November 25, 2019
Study Completion Date
December 4, 2019
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.
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.
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.
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.
enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.
DualDur Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.
MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections, Vienna
Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd., Budapest
Praxis Dr.med. Reinhardt, Pforzheim
FORBELI s.r.o., Prague
Neurologická ambulance, Prague
St. Luke's Clinic, Gdansk
Centrum Dr. Ozimek, Warsaw
Borélia centrum Bratislava, BCB Clinic, Bratislava
Lead Sponsor
Collaborators (1)
Pharmahungary Group
INDUSTRY
Lyme Diagnostics Ltd.
INDUSTRY