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OpenTrials
Completed

NCT Number: NCT02547636

Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.

Completed

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Key information

Conditions

Evaluation of Test Panel

Sex eligibility

All sexes

Study type

Observational

Primary location

Navy Medical Center San Diego/Naval Health Research Center, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Whole blood (prospectively collected via informed consent):
  • Adult subject has a recorded or self-reported fever within the previous 24 hours
  • Subject provides informed consent prior to enrollment and specimen collection
  • Subject has not previously provided a whole blood specimen for this study

Whole blood (residual)

  • Whole blood (in EDTA) submitted to laboratory for standard of care testing
  • Specimen is not from an individual with a specimen previously enrolled in the study

Positive Blood Culture:

  • Culture was detected as positive by an automated blood culture system
  • Culture is not from a patient previously enrolled in the study

Negative Blood Culture:

  • Culture not detected as positive by an automated blood culture system
  • Culture is not from a patient previously enrolled in the study

Sputum:

  • Specimen was accepted for testing by the respective site's microbiology laboratory
  • Specimen is not from an individual that has a sputum already enrolled in the study

Treatment and study plan

observational study

Other

No intervention will be used in this study.

Primary outcomes

  1. Clinical specificity of the FilmArray NGDS Warrior Panel

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

BioFire Diagnostics, LLC

Industry

Collaborators

  • BioFire Defense LLC

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.