Yersinia Pestis Lateral Flow Immunoassay for Blood Samples

Summary

Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could be used against US warfighters. Although this bacterium is ecologically established worldwide, it mostly affects impoverished people who live in rural low-resource areas of Madagascar. Plague is acquired directly from bites of infected fleas but, if left untreated, it can progress to the highly lethal pneumonic form that can result in human to human transmission. With the dangers of pneumonic plague in the context of both natural outbreak and as a bioweapon used against warfighter, the goal of this study is to investigate a diagnostic test that is able to rapidly and locally diagnose this disease in low-resource settings. This study aims to evaluate a US-developed new LFI (Lateral Flow Immunoassay) assay intended for capillary blood (finger-prick) to diagnose humans infected with Y. pestis. The investigators will rigorously validate with assay on human populations from active plague sites and correlate the results with the results of paired clinical samples used in standard medical workup using existing diagnostics tests.

Conditions

• Plague
• Plague, Bubonic
• Plague, Pneumonic
• Yersinia Pestis Plague
• Yersinia Pestis; Bubo
• Yersinia Pestis; Pneumonia
• Yersinia Sepsis
• Yersinia Pestis Infection
• Bubo; Yersinia Pestis
• Bubonic; Plague, Skin
• Pneumonic Plague

Interventions

DIAGNOSTIC_TEST

Lateral Flow Assay for Pathogens of the Plague

A dipstick type of rapid test for antigens of the plague bacterium Yersinia pestis in samples from enrolled participants from both a known geography of plague activity (Madagascar) as well as samples from a geographically separated population of likely plague free status (US Naval Health Research Center, San Diego, CA).

Sponsors & Collaborators

• Northern Arizona University

  collaborator OTHER

• New Horizons Diagnostics Corporation

  collaborator UNKNOWN

• Institut Pasteur de Madagascar

  collaborator OTHER

• Naval Health Research Center

  collaborator FED

• Brimrose Technology Corporation

  lead INDUSTRY

Principal Investigators

• Dawn J Birdsell, Ph.D. · Northern Arizona University

• David M Wagner, Ph.D. · Northern Arizona University

• Minoarisoa Rajerison, Ph.D. · Institut Pasteur de Madagascar

• Voahangy Andrianaivoarimanana, Ph.D. · Institut Pasteur de Madagascar

• Chris Myers, Ph.D. · Naval Health Research Center

• Caroline Balagout · Naval Health Research Center

• David P Trudil · New Horizons Diagnostics, Inc./Brimrose Biotechnology, Corp.

Eligibility

Min Age

5 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2022-12-31

Completion

2023-01-31

FDA Device

Yes

Countries

• United States
• Madagascar

Study Locations