An observational study in Streptococcal Pharyngitis and Group A Streptococcal Infection, sponsored by SalivIQ Diagnostics, Inc.. Not yet recruiting at 3 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by SalivIQ Diagnostics, Inc. · Observational
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:
Participants will:
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.
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%.
159 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.
This study's planned enrollment of 668 is above the median of 358 across 43 observational studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →This is the only study on the registry with SalivIQ Diagnostics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: qPCR
molecular test
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Saliva Specimens
Positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of SalivIQ™ Strep A using saliva specimens will be calculated relative to reference β-hemolytic GAS throat culture, with corresponding two-sided 95% confidence intervals. PPV and NPV will be calculated using observed study prevalence, and prevalence-adjusted expected PPV and NPV will also be estimated using an assumed 30% prevalence.
Time frame: Day 1
Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Throat Swab Specimens
Positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of SalivIQ™ Strep A using throat swab specimens will be calculated relative to reference β-hemolytic GAS throat culture, with corresponding two-sided 95% confidence intervals. PPV and NPV will be calculated using observed study prevalence, and prevalence-adjusted expected PPV and NPV will also be estimated using an assumed 30% prevalence.
Time frame: Day 1
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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