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Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts

NCT06379061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2025-06-05

No results posted yet for this study

Summary

The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.

Conditions

  • Infection, Bacterial
  • Infection Viral

Interventions

OTHER

Adult and Pediatrics

This is an observational study. This protocol is for blood draw enrollment. These samples will be collected and binned by their results from the MeMed BV assay. Samples collected will be used for an analytical comparison study under a future testing protocol. These samples will be used to establish the diagnostic performance of MeMed BV test on BEC Access Immunoassay Systems for differentiating bacterial from viral infection.

Sponsors & Collaborators

  • MeMed Diagnostics Ltd.

    collaborator INDUSTRY

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • David Haan · Beckman Coulter, Inc.

Eligibility

Min Age
90 Days
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-01-31
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379061 on ClinicalTrials.gov