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.
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 Type
OBSERVATIONAL
Enrollment
650
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.
Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Brigham
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Blood Specimen Collection
Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection
Time frame: Less or equal to seven days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.