Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)
NCT05439551 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215
Last updated 2023-10-24
Summary
This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.
Conditions
- Acute Infection
Interventions
- DIAGNOSTIC_TEST
-
MeMed BV®
Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management.
Sponsors & Collaborators
-
MeMed Diagnostics Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 90 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-11
- Primary Completion
- 2022-11-13
- Completion
- 2023-09-29
- FDA Device
- Yes
Countries
- United States
- Israel
Study Locations
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