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Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02547636
Enrollment
1822
Registered
2015-09-11
Start date
2015-12-31
Completion date
2016-12-31
Last updated
2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of Test Panel

Brief summary

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

Interventions

OTHERObservational study

No intervention will be used in this study.

Sponsors

BioFire Defense LLC
CollaboratorINDUSTRY
BioFire Diagnostics, LLC
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical specificity of the FilmArray NGDS Warrior Panel8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026