Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMicrobio Co Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- InfectID-BSI (Bloodstream Infection) qPCR Assay
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov