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

Mahidol University

Status: Completed

Conditions: Pharyngitis

Treatments: Device: QuickVue; Device: Sofia; Device: Throat swab culture

Study type: Interventional

Funder types: Other

Identifiers

NCT02623985

539-2558-EC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Sofia

Experimental group

Description:

Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test.

Treatment:

Device: Sofia

QuickVue

Experimental group

Description:

Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test.

Treatment:

Device: QuickVue

Throat swab culture

Experimental group

Description:

Patients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard.

Treatment:

Device: Throat swab culture