Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat

Not Applicable

Completed

• Conditions: Pharyngitis
• Interventions: Device: Sofia; Device: QuickVue; Device: Throat swab culture

• Registration Number: NCT02623985
• Lead Sponsor: Mahidol University

Brief Summary

The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic streptococci in patients who presented with sore throat at out patient department in Siriraj Hospital.

Detailed Description

The patients who presented with sore throat at out patient department less than 5 days and age over 6 years old would be enrolled by the primary physicians and the consent forms will be completed by researcher.

The throat swab would be performed by using Sofia, QuickVue rapid tests compare to the gold standard which is a throat swab culture to evaluate the accuracy of the rapid tests.

The sample size for validation of sensitivity and specificity of rapid tests is 358 patients.

The primary outcome is will be evaluated sensitivity and specificity of both rapid tests.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2015-11-26
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients who came with sore throat less than 5 days.

Read More

Exclusion Criteria

• No

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofia	Sofia	Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test.
QuickVue	QuickVue	Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test.
Throat swab culture	Throat swab culture	Patients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard.

Primary Outcome Measures

Name	Time	Method
Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test.	Day 1	Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are negative for Group A Streptococcus by Sofia rapid test.	Day 1	Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are positive for Group A Streptococcus by QuickVue rapid test.	Day 1	Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are negative for Group A Streptococcus by QuickVue rapid test.	Day 1	Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.