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

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.

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Key information

Conditions

Bloodstream Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

The Prince Charles Hospital, Chermside, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Determine the sensitivity and specificity of InfectID-BSI versus blood culture.

Time frame: Through study completion, an average of 1 year

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.
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.

Time frame: Through study completion, an average of 1 year

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi DeFazio

CONTACT

[email protected]

+61410661035

Sponsors and collaborators

Lead sponsor

Microbio Co Ltd

Industry

Registry information

Official study title

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

Acronym: IID-BSIqPCR

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 31, 2024
Registry last updated: Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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