A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease

Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any
study-related procedures.

2. Male or female subjects who are at least 18 years of age.

3. Subjects are suspected to have early Lyme disease based on the following criteria:
Signs, symptoms and clinical history consistent with early-stage Lyme disease.
Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and
should have systemic symptoms indicative of disseminated infection. Symptoms may
include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute
and convalescent titers will be drawn (first draw at time of initial visit and second
draw 4 weeks later) or,

4. Subjects are suspected to have late Lyme disease based on the following criteria:
Signs, symptoms and clinical history consistent with late stage Lyme disease,
including but not limited to disseminated rash, arthritis, meningitis, facial palsy,
or carditis.

5. Subjects must be willing and have the ability to safely have the required quantity of
blood drawn for the study at the discretion of the investigator.

6. Subjects must have blood samples freshly collected (no supplemental frozen samples)
and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being
drawn.

Exclusion Criteria:

1. Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as
being associated with Lyme disease.

2. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood
sample collection.

3. Immune deficiency significant enough to render serological tests less reliable.

4. The subject is unwilling or unable to safely have the required quantity of blood drawn
for this study.

5. Subjects who are not able to understand all of the requirements of the study or unable
to give informed consent and/or comply with all aspects of the evaluation.

6. Subjects that have any other condition or situation which, in the opinion of the
investigator, would make the subject unsuitable for enrollment or could interfere with
the subject participating in and completing the study.

7. Subjects that have undergone testing for Lyme disease within the past year.

8. Subjects that have a prior diagnosis of Lyme disease.