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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06379061
Study type Observational
Source Beckman Coulter, Inc.
Contact Wendy Nelson, PhD
Phone 6513370598
Email wdnelson@beckman.com
Status Recruiting
Phase
Start date June 12, 2024
Completion date March 31, 2025

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