Diagnostic Device for Norovirus Gastroenteritis

Infectious diseases can have significant impact on operational readiness of military forces. This proposal describes a rapid immunochromatographic diagnostic test (Noro Detect™) for gastroenteritis caused by Norovirus (NoV) infection. The test can potentially be used in combination with a portable reader (powered by rechargeable batteries) for automated reading and interpretation. The proposed solution is small, lightweight, and insensitive to environmental extremes such as dust, high humidity, and storage temperatures of up to 45°C. The test will have high sensitivity and specificity to differentiate from other enteric pathogens, and can detect norovirus infection at the onset of symptoms. Time to result is expected to be 20-30 minutes, and many tests can be run in parallel. Major advantages of this diagnostic method are that it is fast, soldier-friendly, non-invasive, and likely to be consistent with obtaining U.S. Food and Drug Administration (FDA) clearance as a Clinical Laboratory Improvement Act (CLIA)-waived diagnostic device. Rapid identification of the diarrhea-causing pathogen will aid immediate intervention. Such a test will have a need for both military and non-military use. InBios will work closely with its distribution channels worldwide to make Noro Detect™ available to government and private reference laboratories/hospitals and at point of care settings.