Antigen Detection Assay for the Diagnosis of Melioidosis

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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 45% and 20% 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 "gold standard" for diagnosis, however this can take 3-5 days. Our goal is to develop a rapid point-of-care lateral flow immunoassay for the detection of the B. pseudomallei capsular antigen (CPS) directly from patient samples. Our previous studies have determined that the CPS is a shed antigen and a prototype LFI has yielded encouraging results. The goals of the project are to (i) produce a library of high affinity CPS specific mAbs (ii) optimize LFI construction, (iii) determine compatibe sample types and sample preparation and (iv) quantify CPS in patient samples. 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. Dr. AuCoin's laboratory is already collaborating with InBios on development of a prototype LFI. In addition, both groups will work closely with experts in endemic areas (Thailand and Australia) who will be conducting evaluation of the LFI with different sample types.