Strep A FIA Field Study, Sofia

Quidel

Status: Completed

Conditions: Group A Streptococcus

Study type: Observational

Funder types: Industry

Identifiers

NCT02153008

CS-0142-07

Details and patient eligibility

About

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

Enrollment: 1,708 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,708 participants in 1 patient group

Symptomatic population for GAS

Description:

This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study.