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

Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast

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 Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Septic Shock; Bloodstream Infection
• Intervention / Treatment: Diagnostic test: InfectID-BSI (Bloodstream Infection) qPCR Assay

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Naomi DeFazio; Phone Number: +61410661035; Email: ndefazio@microbio.com.au

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
      • Contact: Naomi DeFazio; Phone Number: +61410661035; Email: ndefazio@microbio.com.au
    • Woolloongabba, Queensland, Australia, 4102
      • The Princess Alexandra Hospital
      • Contact: Naomi DeFazio; Phone Number: +61410661035; Email: ndefazio@microbio.com.au
• United Kingdom
  • Bristol, United Kingdom
    • Southwest Regional Laboratory, UK Health Security Agency, Bristol UK
    • Contact: Naomi DeFazio; Phone Number: +61410661035; Email: ndefazio@microbio.com.au
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
      • Contact: Naomi DeFazio; Phone Number: 3179445000; Email: ndefazio@microbio.com.au
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
      • Contact: Naomi DeFazio; Phone Number: 4107063100; Email: ndefazio@microbio.com.au
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • TriCore Reference Laboratories
      • Contact: Naomi DeFazio; Phone Number: 5059388888; Email: ndefazio@microbio.com.au
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Centre
      • Contact: Naomi DeFazio; Phone Number: 6153225000; Email: ndefazio@microbio.com.au
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study seeks to enroll neonates (less than 1 month of age), pediatrics (between 1 month and 17 years of age) and adults (>18 years of age) who are suspected to have a blood stream infection (BSI /Sepsis).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the sensitivity and specificity of InfectID-BSI versus 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.	Through study completion, an average of 1 year
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.	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Microbio Co Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: MB-CLA-PRT-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No