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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03099018

Enrollment

1000

Registered

2017-04-04

Start date

2014-06-30

Completion date

2016-11-30

Last updated

2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis

Keywords

GAS, pharyngitis, children, RADT

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).

Interventions

DIAGNOSTIC_TESTSofia 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 15 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis	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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026