This study is currently not recruiting participants.

DE-IDENTIFIED RESIDUAL BLOOD CULTURE SAMPLE COLLECTION

Study on Blood Culture Identification Tests

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this investigational study is to collect clinical samples in order to establish the analytical and clinical performance characteristics of the GenMark in vitro diagnostic Sample-to-Answer Blood Culture Identification Gram Positive and Gram Negative Panels (IVD), to support regulatory premarket submissions/notifications.

Detailed description of study

The purpose of this investigational study is to collect clinical samples in order to establish the analytical and clinical performance characteristics of the GenMark in vitro diagnostic Sample-to-Answer Blood Culture Identification Gram Positive and Gram Negative Panels (IVD), to support regulatory premarket submissions/notifications.

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 effectiveness of a blood test designed to identify bacteria in blood samples. The purpose is to determine how well these tests work in identifying different types of bacteria, which can be important for diagnosing infections.

Participants will have clinical samples collected. These samples will be used to test the performance of the blood culture identification panels, which are tools to help detect bacteria in blood samples.

  • Who can participate: General eligibility criteria include age and health status, although specific details are not provided.
  • Study details: Participants will provide samples for testing to evaluate the panels' ability to identify bacteria in blood samples.
Updated on 19 Feb 2024. Study ID: 1402555177

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