Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
NCT05672875 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 343
Last updated 2023-11-30
Summary
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive samples.
Conditions
- Anthrax
Interventions
- DIAGNOSTIC_TEST
-
Anthrax LF Dx System
Lateral flow immunoassay for the detection of the LF biomarker in whole blood samples.
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
SRI International
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-01-23
- Primary Completion
- 2023-04-20
- Completion
- 2023-04-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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