Trials / Completed
CompletedNCT05439551
Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)
A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 215 (actual)
- Sponsor
- MeMed Diagnostics Ltd. · Industry
- Sex
- All
- Age
- 90 Days
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-02-11
- Primary completion
- 2022-11-13
- Completion
- 2023-09-29
- First posted
- 2022-06-30
- Last updated
- 2023-10-24
Locations
5 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05439551. Inclusion in this directory is not an endorsement.