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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.
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
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