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

Streptococcal Pharyngitis, Group A Streptococcal Infection

SalivIQ, SalivIQ Strep A, Strep A, Strep Throat, Group A Streptococcus, GAS, Streptococcus pyogenes, Pharyngitis, Saliva Test, Molecular Diagnostic, Point-of-Care Testing, qPCR

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.

This is an observational, multicenter, double-blinded clinical study designed to evaluate the diagnostic performance of the SalivIQ™ Strep A test for detecting Group A Streptococcus (GAS) in saliva and throat swab specimens. The study will enroll pediatric and adult participants 3 years of age and older who present with signs and symptoms of acute pharyngitis. Testing will be conducted by untrained operators at a minimum of three geographically diverse, Clinical Laboratory Improvement Amendments (CLIA)-waived clinical sites in the United States. Approximately 668 participants are expected to be enrolled. Enrollment will continue until at least 100 evaluable GAS-positive cases, as confirmed by beta-hemolytic throat culture, have been obtained. Final enrollment may be lower or higher than 668 depending on the observed prevalence of GAS, participant evaluability, and the distribution of pediatric and adult participants. Each participant will provide specimens for standard-of-care, reference, and investigational testing. These include one throat swab for a standard-of-care rapid antigen Strep A test; a double throat swab collected simultaneously, with one swab used for reference beta-hemolytic throat culture and one used with the SalivIQ™ Strep A test; and one saliva specimen for testing with the SalivIQ™ Strep A test. The standard-of-care rapid antigen throat swab will always be collected first. The order of the SalivIQ saliva specimen and double throat swab collection will be randomized, with at least 5 minutes between the standard-of-care throat swab and the double throat swab. The primary objective is to determine the sensitivity and specificity of the SalivIQ™ Strep A test when performed by untrained operators using saliva and throat swab specimens, compared with reference beta-hemolytic GAS throat culture. Diagnostic performance will be evaluated separately for the saliva and throat swab specimen types. The secondary objectives are to compare SalivIQ™ Strep A results with an FDA-cleared rapid antigen Strep A test; assess patient and provider satisfaction with test usability and workflow fit; assess clinical utility using antibiotic prescription data; and assess clinical utility among participants who have had a tonsillectomy. Clinical performance measures will include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and measures of agreement. These measures will be calculated separately for saliva and throat swab specimens. The performance targets are at least 95% overall sensitivity and specificity, with the lower bound of the 95% confidence interval at least 90%.

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