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

NCT ID: NCT02623985

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Pharyngitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sofia

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

Group Type: EXPERIMENTAL

Sofia

Intervention Type: DEVICE

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

QuickVue

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

Group Type: EXPERIMENTAL

QuickVue

Intervention Type: DEVICE

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

Throat swab culture

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

Group Type: EXPERIMENTAL

Throat swab culture

Intervention Type: DEVICE

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

Interventions

Sofia

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

Intervention Type: DEVICE

QuickVue

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

Intervention Type: DEVICE

Throat swab culture

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

Intervention Type: DEVICE

Other Intervention Names

Sofia for rapid test; QuickVue for rapid test; throat swab culture for gold standard

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Adhiratha Boonyasiri

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Plainvert C, Duquesne I, Touak G, Dmytruk N, Poyart C. In vitro evaluation and comparison of 5 rapid antigen detection tests for the diagnosis of beta-hemolytic group A streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2015 Oct;83(2):105-11. doi: 10.1016/j.diagmicrobio.2015.06.012. Epub 2015 Jun 23.

Reference Type: BACKGROUND

PMID: 26159722 (View on PubMed)

Other Identifiers

539-2558-EC1

Identifier Type: -

Identifier Source: org_study_id