Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06531031

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

Sponsor: Microbio Co Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2025-08

Completion Date

2026-11

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

Locations (8)

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