NCT06531031

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Microbio Co Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-07-31
• Last updated: 2025-07-24

Locations

8 sites across 3 countries: United States, Australia, United Kingdom