Sofia 2 Lyme FIA Whole Blood Clinical Study

The objective of this study is to demonstrate the clinical performance of the Sofia® 2
analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to
Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,
whole blood and serum from symptomatic subjects. The finger-stick and venous whole blood
specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover
whole blood) and serum specimens will be sent to a separate reference laboratory for testing
to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared
predicate test(s). The results of this study may be used to support a 510(k) and/or
CLIA-Waiver submission for testing whole blood sample types.

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 diagnostic testing and/or prescribed a ≥10 day course of
antibiotics such as doxycycline in patients > 8 years old or amoxicillin, cefuroxime or
doxycycline in patients ≤8 years of age.

Arm 2 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the
past 16 months, a physician must have previously diagnosed the subject based on the
presence of an EM rash or based on symptoms and confirmed by laboratory findings as
outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record
documenting the diagnosis must be obtained, and kept as source documentation at the
enrolling site.

Arm 3 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the
past 17 to 50 months, a physician must have previously diagnosed the subject based on the
presence of an EM rash or based on symptoms and confirmed by laboratory findings as
outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record
documenting the diagnosis must be obtained, and kept as source documentation at the
enrolling site.

Exclusion Criteria:

- Unable to understand and consent to participation; for minors this includes parent or
legal guardian.