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

Exclusion Criteria

• •Man or female subjects over 80 years of age
• •Pregnancy, breastfeeding
• •History of any complication related to previous blood sampling
• •Coagulation and/or bleeding disorders
• •Anticoagulant therapy
• •Acute, life-threatening condition
• •Participation in another clinical trial
• •The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
• •The patient is currently taking or has taken in the preceding 6 months dietary supplements of herbal origin, or medicinal herbs as first-line or add-on treatments for Lyme borreliosis
• •In the event the patient has previously been treated for Lyme borreliosis, then this treatment took place less than 6 months before blood sampling.
• •In the preceding 6 months, the patient used an electronic device operating along the principle of electromagnetic (i.e. electric or magnetic) fields - such as bioresonance, pulsed magnetic field, etc. - as add-on treatment for Lyme borreliosis.
• •II. Negative trial arm
• •Man or female subjects over 80 years of age
• •Pregnancy, breastfeeding
• •History of any complication related to previous blood sampling
• •Coagulation and/or bleeding disorders
• •Anticoagulant therapy
• •Participation in another clinical trial
• •Lyme borreliosis diagnosed previously, at any time during the life of the subject
• •The subject has received any treatment for Lyme borreliosis (medicinal products, dietary supplements, medicinal plants, electronic devices, etc.) during his/her life
• •The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
• •The occupation of the subject is either a forester or a hunter