Group A Streptococcus
Conditions
Keywords
Strep throat
Brief summary
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
Interventions
None listed
Sponsors
Quidel Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Group A Streptococcus | Within 5 minutes | A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer |
Countries
United States
Outcome results
None listed