Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
1 other identifier
observational
450
1 country
4
Brief Summary
The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be contrived to be positive.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
March 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2020
CompletedFebruary 10, 2021
February 1, 2021
9 months
March 22, 2020
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The estimated specificity of the AAD Plus test.
For the estimated specificity, the negative percent agreement (NPA) will be calculated from testing unspiked specimens from 400 subjects (with presumed negative samples).
Day of enrollment.
Secondary Outcomes (1)
The percent positive agreement (PPA)
Day of enrollment.
Interventions
A lateral flow immunoassay rapid test (AAD Plus) for early and presumptive diagnosis of inhalational anthrax.
Eligibility Criteria
Male and female subjects, 18 to 90 years of age, with symptoms consistent with cold, flu or other bronchial and febrile infections.
You may qualify if:
- Male or female, 18 to 90 years of age.
- Current symptoms consistent with cold, flu or other bronchial and febrile infections. The subject must currently (day of consent) have at least one of the following symptoms: fever, chills, chest discomfort, shortness of breath, cough, dizziness/confusion, nausea, headache, sweats, fatigue, or body aches.
You may not qualify if:
- Nursing home residents
- Inmates/subjects in police custody
- Unable to understand verbal or written language of the consent or require a Legal Authorized Representative for consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, 85283, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Biospecimen
8 milliliters of blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marketa Hnilova, PhD
InBios International
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2020
First Posted
March 25, 2020
Study Start
March 25, 2020
Primary Completion
December 17, 2020
Study Completion
December 17, 2020
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share