Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Microbio Co Ltd
- Enrollment
- 1,500
- Locations
- 8
- Primary Endpoint
- Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Two additional EDTA blood sample/s collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).
- •EDTA blood volume is ≥1mL.
- •EDTA blood sample is stored according to Microbio's stability requirements.
Exclusion Criteria
- •No suspicion of blood stream infection (BSI).
- •Any inclusion criterion not met.
- •Multiple EDTA blood samples from the same patient.
- •EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.
- •Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.
- •EDTA blood samples that have not been stored according to Microbio's sample stability requirements.
- •EDTA blood volume <1mL.
Outcomes
Primary Outcomes
Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species.
Time Frame: Through study completion, an average of 1 year
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. InfectID has it's own reporting software - InfectID-Client which is how the InfectID-BSI results will be reported for the study.
Determine the sensitivity and specificity of InfectID-BSI versus blood culture.
Time Frame: Through study completion, an average of 1 year
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.
Secondary Outcomes
No secondary outcomes reported