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:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT06746259
Brief Summary:
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is:
• Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.
Detailed Description:
A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test.
The study aims to:
* Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result.
* As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.
Study:
NCT06746259
Study Brief:
Protocol Section:
NCT06746259