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

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 Overview

• Status: Completed
• Conditions: Pharyngitis
• Intervention / Treatment: Diagnostic test: Sofia Strep A FIA

• Study Type: Observational
• Enrollment (Actual): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis	Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Quidel Corporation
• Investigators: Principal Investigator: Laurence Lacroix, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: children; pharyngitis; GAS; RADT
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: 13-248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No