Sofia Strep A FIA Field Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01494792

Enrollment

2090

Registered

2011-12-19

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group A Streptococcus, Strep Throat

Brief summary

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Interventions

DEVICEIn Vitro Diagnositc aid for diagnosis

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion criteria

* Presence of sore throat * Redness of the posterior pharyngeal wall * Tonsillar exudate * Tonsillar swelling * Tender anterior cervical adenopathy * Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS: * Rash, typical of scarlet fever * Abnormal tympanic membranes * Palatal petechiae

Exclusion criteria

* Subjects treated with antibiotics currently or within the previous week (7 days) 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026