Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 1,000
- Primary Endpoint
- Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Laurence Lacroix
MD, Pediatric Emergency Physician
University Hospital, Geneva