Strep A FIA Field Study, Sofia

Sofia Strep A FIA Field Study

To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

Inclusion Criteria:

1. Male and Female, 3 years of age or older
2. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.

For example:

1. Acute onset of sore throat

2. Redness of the posterior pharyngeal wall

3. Difficulty/pain on swallowing

4. Fever, > 37.8º C (100ºF) at presentation or within past 24 hours

5. Pharyngeal exudate

6. Tender cervical lymphadenopathy

7. Absence of cough, runny nose or other upper respiratory symptoms.*

8. Other, symptoms specific to Strep A not listed above.

   • Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.

Exclusion Criteria:

1. Subjects currently under treatment with antibiotics are not to be included in this study.
2. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.