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

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.

Study Overview

• Status: Completed
• Conditions: Anthrax
• Intervention / Treatment: Diagnostic test: Active Anthrax Detect™ Plus (AAD Plus)

Detailed Description

This study is a multi-site trial assessing the clinical specificity of AAD Plus using capillary blood, venous blood, and venous serum samples collected from presumptive anthrax negative subjects who present with symptoms consistent with cold, flu or other bronchial and febrile infections in the US. At least 440 subjects who meet the study eligibility criteria will have 3 blood samples from a single time point tested with the AAD Plus device. The samples will be: 1) capillary blood collected by finger stick; 2) venous blood collected in a sodium citrate anticoagulant tube; and, 3) serum obtained from venous blood collected in a serum separator tube. The capillary blood sample will be tested immediately to avoid clotting by an unblinded staff member. The venous blood and serum samples will be tested by a blinded staff member as soon as possible after preparation. Additional aliquots of the serum sample will be prepared and stored frozen at -20 ± 2°C or colder for possible additional reference testing [CDC reverse-transcriptase polymerase chain reaction (RT-PCR) assay (K140426)] in the event that any of the subject's capillary blood, venous blood, or serum sample is positive.

At each clinical site, subjects' paired venous whole blood and serum samples will be randomly selected such that 10% of all subjects' samples (total of 40) will be spiked with recombinant anthrax lethal factor (LF) to prepare a contrived positive sample. Each clinical site will be provided a unique randomization list by the Data Management Center that identifies, which subjects will be randomized for spiking with LF. The numbers of spiked samples will be distributed approximately equally between all sites. An unblinded site staff member will prepare the blinded, spiked (from 40 subjects selected for spiking) and unspiked (from 400 subjects that are not selected for spiking) venous blood and serum specimens to be tested by a blinded staff member. Before the venous blood sample and serum specimens (from subjects selected for spiking) are spiked; the unblinded staff member will also test all unspiked samples on the AAD Plus and record the results. Then the spiked venous blood and serum sample will be given to the blinded staff member for testing. Thus, blinded staff will receive whole blood and serum samples that could be either unspiked (presumed negative) or spiked (presumed positive) to preserve the blind. In the rare event that the AAD Plus test result is positive on the unspiked sample tested by the unblinded staff member, then the unblinded staff member will give the unspiked sample from this subject to the blinded operator for AAD Plus testing and the subject's serum sample will be sent for reference testing as described above. Blinded staff will remain blinded throughout the study to the contrived spiking of the whole blood and serum samples as to which samples were contrived.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine/CCT Research
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Hometown Urgent Care and Research
    • Columbus, Ohio, United States, 43214
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female subjects, 18 to 90 years of age, with symptoms consistent with cold, flu or other bronchial and febrile infections.

Description

Inclusion Criteria:

1. Male or female, 18 to 90 years of age.
2. 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.

Exclusion Criteria:

1. Nursing home residents
2. Inmates/subjects in police custody
3. Unable to understand verbal or written language of the consent or require a Legal Authorized Representative for consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent positive agreement (PPA)	The percent positive agreement (PPA) of the contrived serum specimens will be calculated under the assumption that all spiked specimens are true positives.	Day of enrollment.

Collaborators and Investigators

• Sponsor: InBios International, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC
• Investigators: Study Director: Marketa Hnilova, PhD, InBios International

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Diagnostics; Anthrax; Lateral flow immunoassay
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Bacillaceae Infections; Anthrax
• Other Study ID Numbers: AAD Plus-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No