MBIO DIAGNOSTICS INC — Department of Health and Human Services SBIR Phase I: NCIRD-034-PHS2020

Description

Legionnaires’ disease is a severe pneumonia caused by inhalation of Legionella bacteria and can cause serious illness resulting in hospitalization and even death. To prevent and control outbreaks, water sources are tested for Legionella, but the current testing methods are either slow (7-14 days) or cannot distinguish between viable and non-viable bacteria. Therefore, there is an urgent need for better testing methods. Here, MBio proposes a method of obtaining sensitive and quantitative results in a test that takes less than 1.5 days and only detects viable bacteria. Speciation and serotyping are also performed within this time. The test includes a 30-hour culturing step followed by a simple assay to determine the presence or absence of rRNA from Legionella. This nucleic assay can discriminate between different Legionella species. When Legionella is detected, an immunoassay reflex test can be run on the same assay platform for serotyping. These tests will be performed on a simple, robust and flexible platform capable of multiplexing and simultaneously performing nucleic acid and immunoassay tests. This platform is also suitable for performing the widely used urinary antigen test for Legionella for diagnosis of Legionnaires’ disease in humans.