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

NCT06531031 | Not Yet Recruiting

• 1 other identifier: MB-CLA-PRT-0022
• Study Type: observational
• Target: 1,500
• Locations: 3 countries
• Sites: 8

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.

Conditions

Bloodstream Infection; Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (2)

• 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

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• No suspicion of blood stream infection (BSI).
• 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.

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (8)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

TriCore Reference Laboratories

Albuquerque, New Mexico, 87102, United States

Location

Vanderbilt University Medical Centre

Nashville, Tennessee, 37232, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

The Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Southwest Regional Laboratory, UK Health Security Agency, Bristol UK

Bristol, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

An additional 2 x EDTA tube will be collected at the same time as routine bloods are collected for suspected sepsis. One EDTA tube will be collected for the purposes of testing on the InfectID-BSI assay, and the 2nd EDTA tube will be collected for the purposes of storing the sample to aid in DNA sequencing for discordant results between InfectID-BSI and standard of care blood cultures.

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Naomi DeFazio

CONTACT

+61410661035; NDeFazio@microbio.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (2); GB (1)