Skip to main content
OpenTrials
Completed

NCT Number: NCT02623985

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No

Treatment and study plan

Sofia

Device

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

Other names: Sofia for rapid test

QuickVue

Device

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

Other names: QuickVue for rapid test

Throat swab culture

Device

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

Other names: throat swab culture for gold standard

Primary outcomes

  1. Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test.

    Time frame: Day 1

    Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.

  2. Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are negative for Group A Streptococcus by Sofia rapid test.

    Time frame: Day 1

    Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.

  3. Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are positive for Group A Streptococcus by QuickVue rapid test.

    Time frame: Day 1

    Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.

  4. Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are negative for Group A Streptococcus by QuickVue rapid test.

    Time frame: Day 1

    Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 8, 2015
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.