Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infection, Bacterial
- Sponsor
- Beckman Coulter, Inc.
- Enrollment
- 650
- Locations
- 4
- Primary Endpoint
- Blood Specimen Collection
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Over 90 days of age.
- •Clinical suspicion of acute bacterial or viral infection.
- •Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
- •Current disease duration ≤ 7 days.
Exclusion Criteria
- •Previously enrolled
- •Insufficient sample volumes obtained
- •For the adult and pediatric populations, \< 1.2 mL serum volume
- •Sample handling errors
- •Another unrelated episode of febrile infection within the past 2 weeks
- •Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
- •≥48 hours of oral antibiotic treatment
- •≥12 hours of intravenous\\intramuscular antibiotic treatment
- •Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
- •A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
Outcomes
Primary Outcomes
Blood Specimen Collection
Time Frame: Less or equal to seven days
Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection