This study is currently not recruiting participants.

T2 Bacterial Panel Pivotal Study

Investigation of a Diagnostic Panel for Bacterial Detection

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to demonstrate the safety and effectiveness of the T2 Bacterial Panel by validating the clinical performance of the panel when compared to blood culture results and/pr known bacteria positive status of prospectively collected clinical specimens and contrived whole blood samples

Detailed description of study

The purpose of this study is to demonstrate the safety and effectiveness of the T2 Bacterial Panel by validating the clinical performance of the panel when compared to blood culture results and/pr known bacteria positive status of prospectively collected clinical specimens and contrived whole blood samples

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 100 years or below
  • Gender: All

This study investigates the safety and effectiveness of a diagnostic tool called the T2 Bacterial Panel. The purpose is to compare how well this panel performs in detecting bacteria in blood samples against traditional blood culture methods. Blood culture is a process where a sample of blood is tested to see if bacteria or other microorganisms are present. The study will use both clinical specimens collected from patients and samples that have been prepared with known bacteria.

Participants in this study will provide blood samples that will be tested using the T2 Bacterial Panel. These results will be compared to the results from traditional blood culture tests to evaluate the panel's accuracy. The study aims to understand how reliable the T2 Bacterial Panel is in identifying bacterial infections in the blood.

  • Who can participate: Eligibility criteria are not specified in the provided information.
  • Study details: Participants will provide blood samples for testing with the T2 Bacterial Panel. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine may be used as a placebo. The results will be compared to traditional blood culture tests to assess accuracy.
Updated on 19 Feb 2024. Study ID: 1607707498

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