Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Lumos Diagnostics
With
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.
Age
12–64
Sex
ALL
Healthy volunteers
Not accepted
