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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2016

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Geneva
  • Collaborator
    • Quidel Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laurence Lacroix, MD, Pediatric Emergency Physician – University Hospital, Geneva
  • Overall Official(s)
    • Laurence Lacroix, MD, Principal Investigator, University Hospital, Geneva

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