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Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)

NCT04320485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Anthrax

Interventions

DIAGNOSTIC_TEST

Active Anthrax Detect™ Plus (AAD Plus)

A lateral flow immunoassay rapid test (AAD Plus) for early and presumptive diagnosis of inhalational anthrax.

Sponsors & Collaborators

Principal Investigators

  • Marketa Hnilova, PhD · InBios International

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2020-12-17
Completion
2020-12-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320485 on ClinicalTrials.gov