Diagnostic Device for Norovirus Gastroenteritis

Infectious diseases can have a significant impact on operational readiness of military forces. This proposal describes a rapid immunochromatographic diagnostic test for gastroenteritis caused by Norovirus (NoV) infection.  The test shall be used in combination with a portable reader for automated reading and interpretation.  Major advantages of this diagnostic method are that it is soldier-friendly, is non-invasive, and provides rapid detection of the presence of infection.  The rapid identification of the diarrhea-causing pathogen will help to initiate immediate intervention.   The military has the need for robust technologies to diagnose patients at or near the point of care to improve clinical outcome and to conserve resources. Patients seen at the military equivalent of an outpatient clinic (Role of Care 1 or 2) must be quickly treated and returned to duty or evacuated to a more capable medical unit (Role of Care 3). Therefore, diagnosis on the day of symptom onset is essential. The proposed capability should test unprocessed clinical samples and provide easily interpretable results.  In military settings, the point of need is frequently an austere environment without, for example, access to typical laboratory infrastructure, reliable electric power, refrigeration or controlled room-temperature storage, or specially trained laboratory personnel. Therefore, the proposed solution should be small, lightweight, and insensitive to environmental extremes such as dust, high humidity, and storage temperatures of up to 45°C.  If electric power is required, it should be provided by rechargeable or disposable batteries. The test will have high sensitivity and specificity to differentiate from other enteric infectious agents.   The current application is aimed at developing a rapid lateral flow-based test to diagnose gastroenteritis caused by Norovirus infection.