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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital, Geneva

Current Primary Outcome: Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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) [ Time Frame: 1 hour ]

sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: March 28, 2017
Date Started: June 2014
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017