NCT02623985

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

Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat From Acute Pharyngitis at Siriraj Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngitis

Interventions

Type	Name	Description
DEVICE	Sofia	Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.
DEVICE	QuickVue	Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.
DEVICE	Throat swab culture	Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2015-12-08
• Last updated: 2022-10-07