Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
NCT ID: NCT06531031
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1500 participants
OBSERVATIONAL
2025-08-31
2026-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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InfectID-BSI (Bloodstream Infection) qPCR Assay
InfectID-BSI technology targets nucleic acid sequences unique to the target analyte. The qPCR raw data collected from InfectID-BSI's 9 assay tubes is analysed by Microbio's InfectID-Client (InfectID-BSI-associated software) and the result is reported as an analyte-detection if the unique target analyte is present or no result if the unique target analyte is absent.
InfectID-BSI is carried out with whole blood from a venous puncture (EDTA). DNA is extracted from a sample of the collected blood using a validated DNA extraction instrument according to the manufacturer's instructions. The extracted DNA is then added to the InfectID-BSI qPCR reagent panel which consists of 9 reaction tubes (6 for bacteria, and 3 for yeast species). The panel is subjected to real-time qPCR using a process of Melt Curve analysis using the Rotor-Gene Q MDx qPCR instrument. The assay report identifies the species present in the sample upon completion. Results are generated within 3 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Microbio Co Ltd
INDUSTRY
Responsible Party
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Locations
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Indiana University Hospital
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
TriCore Reference Laboratories
Albuquerque, New Mexico, United States
Vanderbilt University Medical Centre
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
The Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
Bristol, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MB-CLA-PRT-0022
Identifier Type: -
Identifier Source: org_study_id
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