CLEU DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Project Summary AbstractInfection is a devastating complication after total joint replacementTJRwith major consequences for patientsincluding a highyear mortality rateandgtand an immense societal burdenConcern for infection is the single most common reason for patients to present to the emergency departmentEDafter TJRlikely because the consequences of a delayed diagnosis can prolong morbidityreduce the chances for successful infection eradicationand sometimes even lead to sepsisDiagnostic errors and unnecessary overtreatment can be just as damaginggiven the multiple aggressive surgical interventions and long termpotentially toxic antibiotic treatment required to manage an infected joint replacementmuch akin to cancer therapyUnfortunatelymaking a diagnosis of infection remains a challenging task for physiciansClinical suspicion alone is ineffective for identifying the presence of infectionas outward clinical signssuch as erythema or swellingare non specific and cannot be differentiated from other forms of inflammationTraditional culturewhich is heavily relied upon by physiciansis slow and has limited sensitivityIsolation of an infecting organism may take greater thanweeks for certain pathogensand as many asof active infections are `culture negativeandaposin that an organism does not appear in cultureOther traditional tests on synovial fluid have limited diagnostic accuracy and must be performed by a technician in a laboratory settingIn factthere is no practical point of carePOCtest available that can allow physicians to quickly and reliably diagnose a joint infection in order to facilitate prompt clinical decisions in real timeCLEU Diagnosticsandaposgoal is to develop the first POC test for infection diagnosis based on a novel electrochemical assay that measures the activity of leukocyte esterasesLEin joint fluidLE are antimicrobial proteases released by activated neutrophils recruited to sites of infectionThe cellular expression of such antimicrobial peptides rises dramatically in response to acute infectionthusthese enzymes serve as ideal biomarkers for joint infectionwith nearly optimal diagnostic accuracyOur approach is driven by our proprietary biosensor technologywhich allows for rapidquantitative detection of LE using low costdisposable screen printed electrodessimilar to glucose meter test stripsCLEU Diagnosticsandaposnovel electrochemical substrates have proven to be highly sensitive for detecting LE in fluid samples with minimal interferenceUltimatelyour novel biosensor will allow physicians in the office or ED to evaluate fluid aspirated from a persistently painful joint replacement with a high diagnostic accuracy in just minutesNot only will this facilitate prompt intervention for those with an infectionbut more commonly it will allow physicians to definitively rule out infection and prevent undue psychological distressand even hospital observationfor those without a joint infectionCLEU Diagnosticsandaposbiosensor may also be highly effective for diagnosing infection in urine and other common biological fluidsincluding cerebrospinalperitonealpleuraland amniotic fluidthusCLEUandapos s technology could have wide ranging applications in medicine Project NarrativeInfection after joint replacement is a devastating complication with a highyear mortality rateandgtand treatment costs that are projected to exceed $billion byThe challenge of making a prompt diagnosis with currently available diagnostic toolswhich are severely limitedhas exacerbated this growing problem and contributes significantly to the prolonged morbidity of this disease processAs the first ever point of care diagnostic testour novel biosensor will revolutionize the management of joint infection by allowing physicians to make highly reliable diagnoses in real time to guide timely clinical decisions and significantly improve a patientandapos s chances for a successful outcome