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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02623985

Enrollment

360

Registered

2015-12-08

Start date

2015-12-31

Completion date

2017-06-30

Last updated

2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis

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.

Interventions

DEVICESofia

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

DEVICEQuickVue

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

DEVICEThroat swab culture

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026