Preview Rapid Strep A Test Method Comparison Study
Suspended
- Conditions
- Strep Throat
- Interventions
- Diagnostic Test: Preview Rapid Strep A test
- Registration Number
- NCT03907449
- Lead Sponsor
- Guangzhou Wondfo Biotech Co., Ltd
- Brief Summary
This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
-
Any patient presenting with symptoms of pharyngitis
- Fever
- Sore throat
- Swollen lymph nodes in neck
- Redness of throat/tonsils
- White/yellow patches on tonsils
- Not currently on antibiotics
-
≥3 years or older
-
Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.
Exclusion Criteria
- Currently taking antibiotics
- Previously enrolled in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Symptoms of Strep Throat Preview Rapid Strep A test Any patient presenting with symptoms of pharyngitis * Fever * Sore throat * Swollen lymph nodes in neck * Redness of throat/tonsils * White/yellow patches on tonsils * Not currently on antibiotics
- Primary Outcome Measures
Name Time Method Accuracy of Preview Strep A Rapid Test 3 months Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UHSH Microbiology
🇺🇸Johnson City, New York, United States
Summerwood Pediatrics
🇺🇸Liverpool, New York, United States