Streptococcal PharyngitisNCT07891728
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
An observational study of Streptococcal Pharyngitis and Group A Streptococcal Infection, run by SalivIQ Diagnostics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Streptococcal Pharyngitis, Group A Streptococcal Infection
- What is being tested?
- qPCR
- How many people
- 668 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Oct 2026to 15 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants will be selected from individuals presenting for clinical care at geographically diverse, CLIA-waived sites in the United States, including urgent care clinics and pediatric practices. Participating sites will use an all-comers or consecutive-enrollment approach while authorized to enroll. The study population will be drawn from the patient populations normally served by these clinical settings and will include both pediatric and adult populations representative of the proposed intended use of the SalivIQ™ Strep A test.
Who may be able to join
- 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
Who cannot join
- Prior antibiotic use within the past 7 days
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
American Family Care
Baton Rouge, Louisiana, 70802
Maryclare Parker, 334-318-0330, mparker@no-resistance.com
PM Pediatrics
Dallas, Texas, 75235
Maryclare Parker, 334-318-0330, mparker@no-resistance.com
American Family Care
North Andover, Massachusetts, 01845
Maryclare Parker, 334-318-0330, mparker@no-resistance.com
About this study
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:
Read more
- 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.
Read the detailed description
This is an observational, multicenter, double-blinded clinical study designed to evaluate the diagnostic performance of the SalivIQ™ Strep A test for detecting Group A Streptococcus (GAS) in saliva and throat swab specimens. The study will enroll pediatric and adult participants 3 years of age and older who present with signs and symptoms of acute pharyngitis. Testing will be conducted by untrained operators at a minimum of three geographically diverse, Clinical Laboratory Improvement Amendments (CLIA)-waived clinical sites in the United States.
Approximately 668 participants are expected to be enrolled. Enrollment will continue until at least 100 evaluable GAS-positive cases, as confirmed by beta-hemolytic throat culture, have been obtained. Final enrollment may be lower or higher than 668 depending on the observed prevalence of GAS, participant evaluability, and the distribution of pediatric and adult participants.
Each participant will provide specimens for standard-of-care, reference, and investigational testing. These include one throat swab for a standard-of-care rapid antigen Strep A test; a double throat swab collected simultaneously, with one swab used for reference beta-hemolytic throat culture and one used with the SalivIQ™ Strep A test; and one saliva specimen for testing with the SalivIQ™ Strep A test. The standard-of-care rapid antigen throat swab will always be collected first. The order of the SalivIQ saliva specimen and double throat swab collection will be randomized, with at least 5 minutes between the standard-of-care throat swab and the double throat swab.
The primary objective is to determine the sensitivity and specificity of the SalivIQ™ Strep A test when performed by untrained operators using saliva and throat swab specimens, compared with reference beta-hemolytic GAS throat culture. Diagnostic performance will be evaluated separately for the saliva and throat swab specimen types.
The secondary objectives are to compare SalivIQ™ Strep A results with an FDA-cleared rapid antigen Strep A test; assess patient and provider satisfaction with test usability and workflow fit; assess clinical utility using antibiotic prescription data; and assess clinical utility among participants who have had a tonsillectomy.
Clinical performance measures will include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and measures of agreement. These measures will be calculated separately for saliva and throat swab specimens. The performance targets are at least 95% overall sensitivity and specificity, with the lower bound of the 95% confidence interval at least 90%.
- Being tested
- qPCR
- Keywords
- SalivIQ, SalivIQ Strep A, Strep A, Strep Throat, Group A Streptococcus, GAS, Streptococcus pyogenes, Pharyngitis, Saliva Test, Molecular Diagnostic, Point-of-Care Testing, qPCR
- Medical subject headings
- Streptococcal Infections, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qPCRDiagnostic test
molecular test
| Study group | Role | What they receive |
|---|---|---|
| Participants With Suspected Group A Streptococcal Pharyngitis | Pediatric and adult participants presenting for clinical evaluation with signs and symptoms of acute pharyngitis will be enrolled in this observational diagnostic study. Participants will undergo standard-of-care rapid antigen Strep A testing and provide specimens for reference beta-hemolytic Group A Streptococcus (GAS) throat culture and investigational SalivIQ™ Strep A testing. SalivIQ™ testing will be performed using both saliva and throat swab specimens. Investigational SalivIQ™ test results will not be used to guide clinical care or treatment decisions. Receives: Diagnostic Test: qPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity of SalivIQ™ Strep A Using Saliva Specimens
Sensitivity of the SalivIQ™ Strep A test using saliva specimens for detection of Group A Streptococcus (GAS), compared with reference β-hemolytic GAS throat culture. Sensitivity will be calculated as the proportion of participants with a positive reference throat culture who also have a positive SalivIQ™ Strep A saliva result, with a two-sided 95% confidence interval.
Measured: Day 1
Diagnostic Specificity of SalivIQ™ Strep A Using Saliva Specimens
Specificity of the SalivIQ™ Strep A test using saliva specimens for detection of Group A Streptococcus (GAS), compared with reference β-hemolytic GAS throat culture. Specificity will be calculated as the proportion of participants with a negative reference throat culture who also have a negative SalivIQ™ Strep A saliva result, with a two-sided 95% confidence interval.
Measured: Day 1
Diagnostic Sensitivity of SalivIQ™ Strep A Using Throat Swab Specimens
Sensitivity of the SalivIQ™ Strep A test using throat swab specimens for detection of Group A Streptococcus (GAS), compared with reference β-hemolytic GAS throat culture. Sensitivity will be calculated as the proportion of participants with a positive reference throat culture who also have a positive SalivIQ™ Strep A throat swab result, with a two-sided 95% confidence interval.
Measured: Day 1
Diagnostic Specificity of SalivIQ™ Strep A Using Throat Swab Specimens
Specificity of the SalivIQ™ Strep A test using throat swab specimens for detection of Group A Streptococcus (GAS), compared with reference β-hemolytic GAS throat culture. Specificity will be calculated as the proportion of participants with a negative reference throat culture who also have a negative SalivIQ™ Strep A throat swab result, with a two-sided 95% confidence interval.
Measured: Day 1
Secondary outcomes (6)
Agreement Between SalivIQ™ Strep A Saliva Results and Rapid Antigen Strep A Test Results
Agreement between SalivIQ™ Strep A results obtained from saliva specimens and results from an FDA-cleared rapid antigen Strep A test. Positive percent agreement, negative percent agreement, and overall percent agreement will be calculated with two-sided 95% confidence intervals.
Measured: Day 1
Agreement Between SalivIQ™ Strep A Throat Swab Results and Rapid Antigen Strep A Test Results
Agreement between SalivIQ™ Strep A results obtained from throat swab specimens and results from an FDA-cleared rapid antigen Strep A test. Positive percent agreement, negative percent agreement, and overall percent agreement will be calculated with two-sided 95% confidence intervals.
Measured: Day 1
Antibiotic Prescribing by SalivIQ™ Strep A Test Result
Antibiotic prescription data will be summarized in relation to SalivIQ™ Strep A, standard-of-care rapid antigen Strep A, and reference throat culture results to assess the potential clinical utility of the investigational test. SalivIQ™ results will not be used to direct participant treatment.
Measured: Day 1
Operator Satisfaction With SalivIQ™ Strep A Testing and Workflow
Untrained operator satisfaction with SalivIQ™ Strep A testing will be assessed using a study usability questionnaire. Measures include ease of use, workflow fit, diagnostic confidence, and willingness to use the test again. Questionnaire items use a 5-point rating scale, with higher scores indicating greater acceptability. Mean scores of 4.0 or greater are expected as a marker of high acceptability.
Measured: Within 7 days after each operator's final study testing session.
Participant Satisfaction With SalivIQ™ Strep A Saliva Collection
Participant satisfaction with SalivIQ™ Strep A saliva collection will be assessed using a study usability questionnaire. Measures include comfort, ease of use, and willingness to use the collection method again. Questionnaire items use a 5-point rating scale, with higher scores indicating greater acceptability. Mean scores of 4.0 or greater are expected as a marker of high acceptability.
Measured: Day 1
Diagnostic Performance of SalivIQ™ Strep A in Participants With a History of Tonsillectomy
Diagnostic performance of the SalivIQ™ Strep A test will be summarized among participants with a history of tonsillectomy to assess test performance and potential clinical utility in this subgroup.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SalivIQ Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA (an IQVIA business)
- Responsible party
- Sponsor
- Investigators
- Julia Halterman, Study chair, SalivIQ Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891728
- Sponsor's protocol ID
- SIQ-2026-002
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided