CompletedNot Applicable

Strep A FIA Field Study, Sofia

United States1,708 participantsStarted 2014-04

Plain-language summary

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

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male and Female, 3 years of age or older
✓. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.
✓. Acute onset of sore throat
✓. Redness of the posterior pharyngeal wall
✓. Difficulty/pain on swallowing
✓. Fever, \> 37.8º C (100ºF) at presentation or within past 24 hours
✓. Pharyngeal exudate
✓. Tender cervical lymphadenopathy

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

Detection of Group A Streptococcus

Timeframe: Within 5 minutes

NCT IDNCT02153008

SponsorQuidel Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-07-01