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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Pharyngitis

Treatments

Diagnostic Test: Sofia Strep A FIA

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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).

Enrollment

1,000 patients

Sex

All

Ages

3 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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