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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pharyngitis

Intervention / Treatment
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* Device: Sofia
* Device: QuickVue
* Device: Throat swab culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who came with sore throat less than 5 days. Exclusion Criteria: No

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sofia<br>Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test. | Device: Sofia<br>* Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.<br>* Other names: Sofia for rapid test;|
| Experimental: QuickVue<br>Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test. | Device: QuickVue<br>* Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.<br>* Other names: QuickVue for rapid test;|
| Experimental: Throat swab culture<br>Patients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard. | Device: Throat swab culture<br>* Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.<br>* Other names: throat swab culture for gold standard;|

What is the study measuring?
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Primary Outcome Measures

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