Table 1.

Inclusion and exclusion criteria

Patients with confirmed Lyme borreliosis

Inclusion criteria:

• Patients ≥18 years with confirmed proven or probable early localized or disseminated Lyme borreliosis manifestation as specified in Additional file 1: Table S1;

• In case of an EM reported at www.tekenradar.nl, the EM has been present < 3 months and the clinical diagnosis has been confirmed by the general practitioner (criteria for clinical diagnosis are described in Additional file 1: Table S1);

• Subjects live or stay on the mainland of the Netherlands.

Exclusion criteria:

• Subjects unable to provide informed consent or not having a sufficient command of the Dutch language;

• Subjects who started antibiotic treatment > 4 days before inclusion (for subjects included through the website www.tekenradar.nl) or > 7 days before inclusion (for subjects included through the clinical expert centers for Lyme borreliosis);

• Subjects who have ongoing signs or symptoms attributed to a previous episode of Lyme borreliosis.

Patients with unconfirmed Lyme borreliosis

Inclusion criteria:

• Myalgia, arthralgia, neuralgia, concentration disorders, cognitive disturbances, with or without fatigue, present for ≥6 months at baseline

• Severity of symptoms assessed by the CIS, SF-36 and/or CFQ questionnaire above the Dutch norm scores;

• Subjects have a negative serological test for B. burgdorferi s.l. (IgG ELISA or C6 IgM/IgG ELISA), but have a history of an unconfirmed suspicion of Lyme disease, based on

• a positive result for a non-recommended diagnostic test (e.g., cellular tests, CD57 analysis, viable blood analysis, bioresonance), or

• onset of disease symptoms that have started within one month after a documented tick bite.

Exclusion criteria:

• Subjects are unable to give informed consent or do not have sufficient command of the Dutch language.