• Percentage of EM positive patients who become MicroB-plex Lyme test positive prior to seroconversion [ Time Frame: Within 14 days of enrollment ]
  MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, becomes positive prior to conventional Lyme immunoassays that measure antibodies in serum, resulting in earlier diagnosis
• Percentage of treated EM positive patients who become MicroB-plex Lyme test negative prior to their decline in serum [ Time Frame: Up to one year from enrollment ]
  MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, becomes negative with successful treatment, prior to a decline in serum antibody level in conventional immunoassays, providing an earlier measure of effective therapy

• MicroB-plex Lyme Test Diagnoses Lyme Early [ Time Frame: Within 14 days of enrollment ]
  MicroB-plex Lyme Test is positive prior to conventional serum test
• MicroB-plex Lyme Test Tracks Successful Therapy [ Time Frame: Up to one year from enrollment ]
  MicroB-plex Lyme Test becomes negative with successful treatment, prior to serum decline

• Lyme Infected
  Subjects presenting with suspected Lyme Disease
  Intervention: Diagnostic Test: MicroB-plex Lyme Immunoassay
• Controls
  Subjects with no known Lyme Disease, past or present
  Intervention: Diagnostic Test: MicroB-plex Lyme Immunoassay

Inclusion Criteria:

1. Human adults at least 21 years of age and no more than 80 years of age at the time of screening.
2. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).
3. High clinical suspicion of acute Lyme disease, with symptoms seven days or less.
4. Must have erythema migrans rash and physician diagnosis of early Lyme disease.
5. Brief history and physical exam will be obtained during the study visit.
6. Be willing to return to our clinic for up to nine visits and blood draws over a one-year period.
7. People who do not have Lyme disease, but want to participate as healthy controls (one time visit)

Exclusion Criteria:

1. Have poor venous access.

2. Have received any immunosuppressive therapy including biologics or recent course of steroids, or recent chemotherapy.

   1. Anti-TNF therapy (eg, adalimumab, etanercept, infliximab).
   2. Intravenous (IV) cyclophosphamide
   3. Interleukin-1 receptor antagonist (anakinra).
   4. Intravenous immunoglobulin (IVIG).
   5. High dose prednisone or equivalent (> 100 mg/day).
   6. Plasmapheresis.
   7. Any new immunosuppressive/immunomodulatory agent
   8. Any steroid injection (eg, intramuscular, intraarticular, or intravenous).
3. On treatment for Lyme disease greater than seven days
4. Recent chemotherapy
5. History of solid organ transplant
6. History of autoimmune disorders (SLE, Rheumatoid arthritis, Scleroderma, etc.)
7. History of inflammatory muscle disease (polymyositis, dermatomyositis, etc.)
8. History of inflammatory bowel disease (Crohn's disease, Ulcerative colitis, etc.)
9. History of HIV infection
10. Received a Lyme disease vaccine in the past
11. History of prior Lyme disease infection in the past
12. Have any condition that, in the opinion of the principal investigator, would significantly increase the risk for the subject.