Trial · NCT07891728
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Saliva Specimens | Day 1 | 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. |
| Other | Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Throat Swab Specimens | Day 1 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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