Antigen Detection assay for the Diagnosis of Melioidosis

DESCRIPTION provided by applicant Burkholderia pseudomallei is a Gram negative bacterium that is the causative agent of melioidosis The bacterium causes significant morbidity and mortality in tropical regions and endemic areas are expanding Melioidosis is difficult to trea and diagnose due to the fact that B pseudomallei is resistant to common antibiotics and symptoms are non specific Mortality rates reach and in Thailand and Australia respectively even with antibiotic treatment Currently there is no validated diagnostic product for the diagnosis of melioidosis Culturing of patient samples is the andquot gold standardandquot for diagnosis however this can take days Our goal is to develop a rapid point of care lateral flow immunoassay LFI for the detection of the B pseudomallei capsular antigen CPS directly from patient samples Phase I STTR Specific Aims focused on producing a library of anti CPS monoclonal antibodies mAbs optimizing the LFI components and sample preparation and performing a feasibility study on archived melioidosis patient samples The objectives of this Phase II application is advanced development and validation of the prototype AMD LFI that incorporates a higher affinity CPS mAb By completing these goals we hope to produce an optimized LFI that possesses sensitivity equal to or greater than culturing of patient samples To achieve these goals we have established an experienced team A strong partnership exists between Dr AuCoinandapos s laboratory and InBios International that has led to the development of an encouraging prototype LFI In addition both groups will work closely with experts in endemic areas Thailand and Australia who will be conducting a large preclinical evaluation of the LFI with different patient sample types PUBLIC HEALTH RELEVANCE Melioidosis is a rapidly progressing and frequently fatal disease if left untreated Burkholderia pseudomallei is the causative agent of melioidosis this soil dwelling bacterium has been listed as a Tier I Select Agent by the CDC In the endemic areas of Thailand and northern Australia melioidosis is a major public health concern Rapid diagnosis of melioidosis is needed in order to properly administer effective treatment with specific antibiotics At present the diagnostic andquot gold standardandquot is culturing of patient samples which takes days and significantly delays administration of proper treatment In this application we offer to develop a point of care cost effective and rapid diagnostic for melioidosis that can deliver results within minutes Such a rapid diagnostic test will have the capability to detect acute B pseudomallei infections in endemic areas as well as following a bioterrorist attack