A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis

NCT07891728 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: SIQ-2026-002
• Study Type: observational
• Target: 668
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Day 1

Secondary Outcomes (6)

• Agreement Between SalivIQ™ Strep A Saliva Results and Rapid Antigen Strep A Test Results

  Day 1

• Agreement Between SalivIQ™ Strep A Throat Swab Results and Rapid Antigen Strep A Test Results

  Day 1

• Antibiotic Prescribing by SalivIQ™ Strep A Test Result

  Day 1

• Operator Satisfaction With SalivIQ™ Strep A Testing and Workflow

  Within 7 days after each operator's final study testing session.

• Participant Satisfaction With SalivIQ™ Strep A Saliva Collection

  Day 1

Other Outcomes (2)

• Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Saliva Specimens

  Day 1

• Additional Diagnostic Performance Measures for SalivIQ™ Strep A Using Throat Swab Specimens

  Day 1

Study Arms (1)

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.

Diagnostic Test: qPCR

Interventions

qPCR DIAGNOSTIC_TEST

molecular test

Participants With Suspected Group A Streptococcal Pharyngitis

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Prior antibiotic use within the past 7 days

Sponsors & Collaborators

• SalivIQ Diagnostics, Inc.: lead
• MCRA (an IQVIA business): collaborator

Study Sites (3)

American Family Care

Baton Rouge, Louisiana, 70802, United States

Location

American Family Care

North Andover, Massachusetts, 01845, United States

Location

PM Pediatrics

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Streptococcal Infections; Pharyngitis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Julia Halterman

  SalivIQ Diagnostics, Inc.

  STUDY CHAIR

Central Study Contacts

Kayla Mirabal

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 23, 2026
• Study Start: October 9, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

US (3)