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RECRUITING
NCT07891728

A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis

Sponsor: SalivIQ Diagnostics, Inc.

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn how well the SalivIQ™ Strep A test detects Group A Streptococcus, the bacteria that cause strep throat. The study will include children and adults with symptoms that may be caused by strep throat. The main questions this study aims to answer are: * How well does the SalivIQ™ Strep A test identify participants who have strep throat? * How well does the SalivIQ™ Strep A test identify participants who do not have strep throat? * How do results from saliva and throat swab samples tested with the SalivIQ™ Strep A test compare with standard laboratory testing? Participants will: * Provide a saliva sample. * Have throat swab samples collected. * Have samples tested using the SalivIQ™ Strep A test and standard laboratory methods. Researchers will compare the SalivIQ™ Strep A test results with standard laboratory test results to determine how accurately the test detects Group A Streptococcus. Participation in the study will not change the medical care participants receive based on their routine clinical testing.

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

OBSERVATIONAL

Enrollment

668

Start Date

2026-10-09

Completion Date

2027-03-15

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

qPCR

molecular test

Locations (3)

Patient Plus Urgent Care

Baton Rouge, Louisiana, United States

American Family Care

North Andover, Massachusetts, United States

PM Pediatrics

Dallas, Texas, United States