Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
Condition: Streptococcal Infections
MeSH terms: Pharyngitis; Streptococcal Infections
Study type: Observational

Summary: 
      The purpose of this study is to determine if the rapid antigen detection test for Group A
      streptococcal pharyngitis diagnosis might yield higher rates of false positive results in
      patients who have been treated for GAS pharyngitis within 28 days of the test.
    

Detailed description: 
      Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and
      above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture.
      However, it has been observed that rapid testing may not be accurate in children with a
      recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of
      rapid strep testing in children who are presenting with symptoms of strep throat, who also
      have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy
      in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary
      testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics,
      and antibiotic resistance.

      The participants in the study will include 600 children, aged 2 to 20 years old, selected
      from a private practice in Northern Virginia who present to the practice with signs or
      symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs
      and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat,
      fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms
      who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the
      study.

      A letter of consent will be provided to the parents and guardians of the involved child,
      stating that the study will be voluntary and confidential, and that all results will be kept
      in a safe environment.

      Investigators will be testing the difference between two proportions, the false positive rate
      in previously treated compared to those not treated.
    

Intervention name(s): Rapid strep antigen detection test; throat culture
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Pharyngeal swab for rapid antigen detection of streptococcus; Pharyngeal swab for culture for bacteria (specifically streptococcus) presence
Other intervention name(s): rapid strep
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The participants in the study will include 600 children, aged 2 to 20 years old, selected
        from a private practice in Northern Virginia who present to the practice with signs or
        symptoms suggestive of acute pharyngitis.

        Potential subjects who have been treated with less than 10 days of antibiotic therapy,
        patients who report non-compliance with previous antibiotic therapy, patients who have
        already been included in the study and children with evidence of GAS carrier status will be
        excluded.
      
Biospecimen description: 
      Throat swabs of the posterior oropharynx will be tested for rapid antigen test and throat
      culture.
    
Keywords: streptococcal infections; rapid strep testing; rapid antigen detection test