What this study is
Simplified from ClinicalTrials.govStudying a saliva and throat swab test (SalivIQ™ Strep A) to see how well it detects Group A strep, the bacteria that cause strep throat, compared with standard lab testing, in people ages 3 and older with acute pharyngitis (a sore, inflamed throat). Taking part will not change the medical care participants receive.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- qPCR
Intervention · DIAGNOSTIC TEST
molecular test
Study details
- Sponsor
- SalivIQ Diagnostics, Inc.
- Conditions
- Streptococcal Pharyngitis · Group A Streptococcal Infection
- Enrolling
- 668 people
- Starts
- 2026-10-09
- Est. completion
- 2027-03-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult patients (age 18 years or older) or minor patients (3-17 years) with an accompanying adult
- Patient exhibits signs and symptoms of pharyngitis, such as sudden onset of sore throat, pain with swallowing, and fever
- Willing and able to provide consent and assent to participate in the study
You can't join if
- Prior antibiotic use within the past 7 days
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Maryclare Parker · Contact334-318-0330mparker@no-resistance.com
Patient Plus Urgent Care
Baton Rouge, Louisiana, United States
RecruitingAmerican Family Care
North Andover, Massachusetts, United States
RecruitingPM Pediatrics
Dallas, Texas, United States
Recruiting
Study team
Sponsor
SalivIQ Diagnostics, Inc.
Study ID SIQ-2026-002
Study chair
Julia Halterman
SalivIQ Diagnostics, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.