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

Launched by MICROBIO CO LTD · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the Microbio InfectID-BSI kit, which aims to quickly detect bacteria and yeast in the blood of patients who might have serious infections like bloodstream infections or sepsis. The goal is to see how well this new test works compared to traditional methods that take longer, helping doctors identify infections more quickly and accurately.

To participate in the trial, individuals must be admitted to the hospital's Intensive Care Unit, Emergency Department, or other medical wards with a suspicion of a bloodstream infection. This includes babies, children, and adults who are at least one month old. Participants will have a blood sample taken, which will be tested using the Microbio kit. It’s important to note that only one blood sample per patient can be used, and it must be collected and stored correctly. If you or a loved one is interested in this trial, it could offer a chance to contribute to important research that may improve future diagnosis and treatment of infections.

Gender

ALL

Eligibility criteria

• 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.
• • Single EDTA blood sample collected from one anatomical site.
• • EDTA blood sample is stored according to Microbio's stability requirements.
• • EDTA blood volume is \>1mL.
• Exclusion Criteria:
• • No suspicion of Blood System Infection.
• • Any Inclusion Criterion not met.
• • Multiple EDTA blood samples from the same patient.
• • EDTA blood samples that have not been stored according to Microbio's stability requirements.
• • EDTA blood volume \<1mL.