NCT03099018

Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).

Conditions

• Pharyngitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sofia Strep A FIA	Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2017-04-04
• Last updated: 2017-04-17