See if SalivIQ Strep A detects strep throat in kids and adults
Official title: A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Run by SalivIQ Diagnostics, Inc. · NCT07891728 · Data updated 2026-11-12
This study tests whether the SalivIQ Strep A test can correctly identify Group A Streptococcus in people with suspected strep throat using saliva and throat swabs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years and up |
| Sex | All |
| Enrollment | 668 (estimated) |
| Sponsor | SalivIQ Diagnostics, Inc. Industry-sponsored |
| Locations | 3 sites (Baton Rouge, Louisiana and 2 other locations) |
| Status | Recruiting |
| Started | October 9, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | March 15, 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07891728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 years and older or adults with signs of pharyngitis who have not used antibiotics in the past 7 days.
✕Probably not a fit
Patients with non-GAS pharyngitis or those unlikely to benefit from rapid testing may not receive diagnostic benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study evaluates the diagnostic performance of the SalivIQ Strep A test for detecting Group A Streptococcus in saliva and throat swabs. It includes adults and children aged 3 years and older who show signs of acute pharyngitis. Participants undergo standard care testing and additional SalivIQ testing, with results compared to reference laboratory tests. The study is conducted at CLIA-waived sites with blinded assessment and aims to enroll about 668 participants to achieve at least 100 GAS-positive cases. The order of specimen collection is standardized to minimize bias.
Why it matters
Potential benefit: If successful, the SalivIQ Strep A test could provide a rapid, noninvasive method to help diagnose strep throat.
How similar studies have gone: Prior studies in similar diagnostic settings have shown promise for saliva- and swab-based tests, but this exact approach with SalivIQ Strep A is being evaluated anew.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior antibiotic use within the past 7 days
Where it's running
-
Patient Plus Urgent Care
Baton Rouge, Louisiana, United States Recruiting -
American Family Care
North Andover, Massachusetts, United States Recruiting -
PM Pediatrics
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Kayla Mirabal
- Email: kayla.mirabal@iqvia.com
- Phone: 919-670-1812
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.