Trial · NCT07891728
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
NCT07891728, Recruiting, SalivIQ Diagnostics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis. Trials, record NCT07891728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
- NCT number
- NCT07891728
- Status
- Recruiting
- Enrollment
- 668 participants, estimated
- Lead sponsor
- SalivIQ Diagnostics, Inc.
- Conditions
- Streptococcal Pharyngitis, Group A Streptococcal Infection
- Interventions
- qPCR
- First posted
- 2026-10-23
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnostic Sensitivity of SalivIQ™ Strep A Using Saliva Specimens | Day 1 | 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. |
| Primary | Diagnostic Specificity of SalivIQ™ Strep A Using Saliva Specimens | Day 1 | 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. |
| Primary | Diagnostic Sensitivity of SalivIQ™ Strep A Using Throat Swab Specimens | Day 1 | 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. |
| Primary | Diagnostic Specificity of SalivIQ™ Strep A Using Throat Swab Specimens | Day 1 | 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. |
| Secondary | Agreement Between SalivIQ™ Strep A Saliva Results and Rapid Antigen Strep A Test Results | Day 1 | 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. |
| Secondary | Agreement Between SalivIQ™ Strep A Throat Swab Results and Rapid Antigen Strep A Test Results | Day 1 | 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. |
| Secondary | Antibiotic Prescribing by SalivIQ™ Strep A Test Result | Day 1 | 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. |
| Secondary | Operator Satisfaction With SalivIQ™ Strep A Testing and Workflow | Within 7 days after each operator's final study testing session. | 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. |
| Secondary | Participant Satisfaction With SalivIQ™ Strep A Saliva Collection | Day 1 | 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. |
| Secondary | Diagnostic Performance of SalivIQ™ Strep A in Participants With a History of Tonsillectomy | Day 1 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891728
GET https://conductscience.org/api/trials/v1/NCT07891728/registered