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

Completed

• Conditions: Pharyngitis

• Registration Number: NCT03099018
• Lead Sponsor: University Hospital, Geneva

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Status Verified: 2017-04
• Study First Posted: 2017-04-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient age between 3 and 15 years
• Clinical diagnosis of pharyngitis
• McIsaac score ≥2

Exclusion Criteria

• Antibiotic treatment in the two weeks preceding the consultation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis	1 hour	Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores)	1 hour	sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score