Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples (IID-BSIqPCR)

Microbio

Status: Not yet enrolling

Conditions: Bloodstream Infection; Septic Shock; Sepsis

Treatments: Diagnostic Test: InfectID-BSI (Bloodstream Infection) qPCR Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT06531031

MB-CLA-PRT-0022

Details and patient eligibility

About

The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.

The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.

Enrollment: 1,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (>18 years of age).
• Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.
• Single EDTA blood sample collected from one anatomical site.
• EDTA blood sample is stored according to Microbio's stability requirements.
• EDTA blood volume is >1mL.

Exclusion criteria

• No suspicion of Blood System Infection.
• Any Inclusion Criterion not met.
• Multiple EDTA blood samples from the same patient.
• EDTA blood samples that have not been stored according to Microbio's stability requirements.
• EDTA blood volume <1mL.