NCT06379061

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 650 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 90 Days – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to collect blood specimens from pediatric (\>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.

Conditions

• Infection, Bacterial
• Infection Viral

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-01-31
• Completion: 2025-04-30
• First posted: 2024-04-23
• Last updated: 2025-06-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study