Assay optimization and adaptation for a customized meter development

Invasive fungal infectionsIFIcaused by ubiquitous mold and yeast is a common cause of negative health outcomes for immunocompromised patientsincluding patients undergo solid organ transplantSOTand hematopoietic stem cell transplantHSCTregularly leading to events such as organ failure or deathCurrent methods for screening IFI rely on laboratory tests that require specialized equipment and professionally trained personnelhence a long turn around time and high costAs a resultthe timing of IFI confirmation is often too late for effective treatmentresulting in significant mortalitymorbidity and financial burden to the family and societyA simple point of carePOCor possibly home used screening test for IFI with shorter time to result will allow screening or even diagnosis at the doctor s office or at homeSuch early diagnosis can lead to more effective therapeutic treatment plan and much improved outcomesIn the Phase I projectwe ve shown that a blood glucose meterBGMcan be used to quantify a bloodglucanBGwith sufficient analytical sensitivity and range comparable to the FDA approved Fungitelltesta k aGlucatellBased on the Phase I resultswe propose to further improve and optimize the BGM based assay forBG using Fungitellassay as the referenceIn additiona small and portable POC system will be developed based on the optimizedBG assay to automate and simplify the testing procedureFinallyclinical validation will be performed using the POCBG test system with human whole blood samples