SalivIQ Diagnostics, Inc.
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…
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
molecular test