Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07308158
Brief Summary:
The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.
The main questions it aims to answer are:
1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, , SARS-CoV-2 and respiratory syncytial virus antigen.
2. What is the overall positive and negative percent agreement between the investigational test and the reference method?
Participants will:
1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
2. Provide an additional specimen for testing with the FDA-cleared reference method.
Study:
NCT07308158
Study Brief:
Protocol Section:
NCT07308158