Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
United States, Madagascar500 participantsStarted 2020-10-19
Plain-language 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.
Who can participate
Age range5 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adults 18 to 75 years old (male and female): Able to receive and give verbal communication.
✓. Children 5 to 17 years old (vulnerable population): Parents or legal guardian must be available to give permission. Parents or legal guardian to consent for children (5-6 years).
✓. Suspected human plague case by local medical professional. Include at least one of the following: For bubonic plague: high fever, chills, and/or presence of painful bubo; For pneumonic plague: high fever, chills, cough for less than 5 days, bloody sputum, and/or chest pains; patients may be recruited from both plague surveillance program and non-plague surveillance programs.
Exclusion criteria
✕. Children under the age of 5 years old
✕. Children between the age of 5 years to 17 years without a parent or legal guardian
✕. Not compliant with the study procedure (blood sampling)
✕. Active duty personnel and DoD beneficiaries that present to participating study sites with influenza-like-illness (fever, cough, sore throat).
What they're measuring
1
LFI results on finger-prick blood correlate with the results of standard WHO-approved diagnostic tests for plague
Timeframe: Up to 3 weeks post sample collection and processing of each participant.
✕. Able to receive/give consent (or assent if \<18 y.o.) 4, Presenting with influenza-like-illness (fever of 100.5 F or higher, cough and/or sore throat)