Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

BioFire Diagnostics

Status: Completed

Conditions: Evaluation of Test Panel

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT02547636

DX-SDY-020450

Details and patient eligibility

About

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

Enrollment: 1,822 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,822 participants in 1 patient group

Subjects/specimens that meet the inclusion criteria

Description:

Subjects/specimens that meet the inclusion criteria

Treatment:

Other: Observational study