Sofia 2 Lyme FIA Whole Blood Clinical Study

Inclusion Criteria: * Arm 1 - Prospective symptomatic subjects, must have had a known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms, and be currently exhibiting the following: * The physician determines that the subject has an expanding erythema migrans (EM) lesion or "bulls-eye rash" with evidence of clearing in the center and has requested 2 tier serological testing or prescribed a ≥10 day course of antibiotics such as doxycycline in subjects \> 8 years old or amoxicillin, cefuroxime or doxycycline in subjects ≤8 years of age: Or \- The physician must observe current symptoms, including: At least three (3) of the listed acute stage symptoms listed: * fatigue * night sweats * chills * fever * headache * arthralgia * mildly stiff neck * myalgia i. one or more symptoms a. through h. are determined to be intermittent Or, * at least one (1) of the following current conditions: * recurrent, brief attacks (weeks/months) of objective joint swelling in one or more joints, sometimes followed by chronic arthritis in one or a few joints, * lymphocytic meningitis * cranial neuritis (partial facial palsy and may be bilateral) * radiculoneuropathy * encephalomyelitis * acute onset of high-grade (2nd or 3rd degree) atrioventricular conduction defects that resolve in days to weeks, sometimes associated with myocarditis In addition, the physician must be sufficiently confident in the possibility of Lyme disease to have requested two-tier diagnosti…