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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Microbio Co Ltd
Study ID
NCT06531031
Status
Not Yet Recruiting

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Conditions

  • Bloodstream Infection
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • InfectID-BSI (Bloodstream Infection) qPCR Assay — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
Jul 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
1,500 participants (estimated)

Primary Outcome Measure

Determine the sensitivity and specificity of InfectID-BSI versus blood culture. [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Indiana University HospitalIndianapolisIndiana46202
Naomi DeFazio
[email protected]
3179445000
University of MarylandBaltimoreMaryland21201
Naomi DeFazio
[email protected]
4107063100
TriCore Reference LaboratoriesAlbuquerqueNew Mexico87102
Naomi DeFazio
[email protected]
5059388888
Vanderbilt University Medical CentreNashvilleTennessee37232
Naomi DeFazio
[email protected]
6153225000
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Indianapolis, IN

By research site
Indiana University Hospital· Indianapolis, INUniversity of Maryland· Baltimore, MDTriCore Reference Laboratories· Albuquerque, NMVanderbilt University Medical Centre· Nashville, TNTexas Children's Hospital· Houston, TX

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