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

Condition(s) studied

Investigational drug(s) / intervention(s)

qPCR: molecular test

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.
• 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.

Trial sites (3)