Lyme Disease Diagnostic Assay - Collection of Whole Blood

Subjects with under evaluation of Lyme Disease Inclusion Criteria: Signs and symptoms of acute Lyme disease which include at least one of the following: * Recent onset of fatigue * Skin rash * Fever * Muscle aches * Neck pain * Joint pain or lymphadenopathy Subgroup Borreliosis Subjects- restricted signs and symptoms of acute Lyme including EM Rash * Under physician or medical evaluation for acute on-set of Lyme Disease presenting with EM Rash * Detailed description of the EM rash (e.g. Itchy, painful, hot, vesicular, raised) with consent for photographic documentation is required including additional picture with ruler placing to confirming size. * EM rash with the following attributes: * Size \> 5 cm in diameter * Appeared 3-30 days after bite or suspected bite * Specify Location (e.g. underarm or back of knee) * Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation * Signs and symptoms (e.g. Fever, Chills/Sweats, Headache, Fatigue/Tiredness, Myalgia/Sore muscles) * The EM rash has been present \<42 days * Clinical diagnosis of Lyme disease is suspected by the practitioner * Ability to provide the minimum sample volume required Exclusion Criteria: * Subjects unable to provide informed consent. * Subjects without clinical information and/or not meeting inclusion criteria. * Subjects having started antibiotic treatment \> 5 days before inclusion. Healthy Subjects Inclusion Criteria: * Apparently healthy subjects with no present fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes, e.g. flu-like symptoms. * Ability to provide the minimum sample volume required. Exclusion Criteria: \- ● Subjects unable to provide informed consent * Subjects without clinical information and/or not meeting inclusion criteria * Subjects with a recent diagnosis of Lyme disease, Anaplasmosis, Babesiosis, or history of known embedded tick bite which may have required 'manual extraction' NOTE: a tick just found on the subject or presence of a crawling tick is not considered a 'tick bite') * Subjects currently on antibiotic treatment. * Uncontrolled HIV-infection, if known. This is defined as an HIV-1 viral load \>40 copies/mL and/or CD4+ count \<500 x 106 cells/liter in the past 12 months. * Active syphilis or leptospirosis, if known * Active infection with Epstein Barr Virus (mononucleosis), if known * Active infection with Cytomegalovirus (CMV), if known * Subjects with autoimmune diseases, either confirmed rheumatoid arthritis and/or other autoimmune disorders diagnosed according to the leading guidelines * Current immunomodulation mediation including \>7.5 mg prednisone daily, methotrexate, and/or biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable. * Immunodeficiency, hematologic malignancies in the medical history * Chemotherapy during the past year