Recruiting

SalivIQ™ Strep A

Sponsor:

SalivIQ Diagnostics, Inc.

Code:

NCT07891728

Conditions

Streptococcal Pharyngitis

Group A Streptococcal Infection

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

qPCR

Study Details

Brief 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.

The main questions this study aims to answer are:

  • 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.

Conditions

Streptococcal Pharyngitis

Group A Streptococcal Infection

Study ID

NCT07891728

Start date

Oct 9, 2026

Status verified date

Oct, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

668 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

qPCR

molecular test

Primary outcome measure

  • Diagnostic Sensitivity of SalivIQ™ Strep A Using Saliva Specimens [ Time Frame: Day 1 ]
  • Diagnostic Specificity of SalivIQ™ Strep A Using Saliva Specimens [ Time Frame: Day 1 ]
  • Diagnostic Sensitivity of SalivIQ™ Strep A Using Throat Swab Specimens [ Time Frame: Day 1 ]
  • Diagnostic Specificity of SalivIQ™ Strep A Using Throat Swab Specimens [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Kayla Mirabal

919-670-1812kayla.mirabal@iqvia.com

Locations

Patient Plus Urgent Care

Recruiting

Baton Rouge, Louisiana, United States, 70802

Contacts

Maryclare Parker

334-318-0330mparker@no-resistance.com

American Family Care

Recruiting

North Andover, Massachusetts, United States, 01845

Contacts

Maryclare Parker

334-318-0330mparker@no-resistance.com

PM Pediatrics

Recruiting

Dallas, Texas, United States, 75235

Contacts

Maryclare Parker

334-318-0330mparker@no-resistance.com

More Information

Sponsor

SalivIQ Diagnostics, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by SalivIQ Diagnostics, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.