A point of care-device for the determination of creatinine phosphokinase (CPK), theCPK Now

Abstract In Vitro Diagnostic Solutions (IVDS) proposes to develop a point-of-care test (POCT) to rapidly determine blood creatine phosphokinase (CPK) activity for the improved management of a range of conditions, including long-chain fatty acid oxidation disorders (LCFAODs) and muscle injuries (e.g., rhabdomyolysis, muscular dystrophy), heart conditions (e.g., heart attack, stroke), and inflammatory diseases (e.g., dermatomyositis, polymyositis). Long-chain fatty acid oxidation disorders are inborn errors of metabolism inherited in an autosomal recessive pattern that result in deficient energy production within the mitochondria and severe downstream effects. Infantile or adolescent-onset LCFAODs are associated with hepatic dysfunction, hypoketotic hypoglycemia, encephalopathy, and intercurrent illness, with severe cases resulting in sudden death. Later or adult-onset LCFAODs are typically associated with muscle weakness, myalgias, and rhabdomyolysis. The prevalence of LCFAODs is about 1 in 10,000 births globally, and it is estimated that LCFAOD patients require 17.55 hospital days per year, comprising a significant time, cost, and effort burden on the patients, and the healthcare system. CPK is an important biomarker for rhabdomyolysis and metabolic decompensation. There is an urgent, unmet need for simple-to-use and accurate home monitoring for CPK determination to help patients manage their hydration, diet, activity levels, and medication. IVDS has pioneered platform that is cost-effective, portable, and is simple-to-use device. Blood can be taken from a finger-stick, heel-stick, or microtainer draw. The platform is based on colorimetric detection via a reflectometer. Test strips provide in situ separation of blood components from plasma and utilize a chemical indicator with absorbance maximum outside the range of common interferents to provide precise detection of CPK activity (U/L). The CPK Now is a single-step, accurate, and rapid POCT requiring only 20 µL of blood. A mobile app displays and stores results of blood CPK levels which can be disseminated to the care provider to make essential decisions on treatment. Successful execution of this proposal will have a lasting, positive impact on those suffering from LCFAODs, muscle injuries, heart conditions, and inflammatory diseases, shifting the clinical paradigms surrounding recurrent rhabdomyolysis and other CPK-related conditions. The project aims are to Aim 1: Evaluate the Production Molded Cassettes and Production Meters. Aim 2: Finalize the CPK Now Mobile Application. Aim 3: Transition from Hand Coating and Hand Assembly to Full Automation. Aim 4: Testing to Regulatory Standards and First Product. Aim 5: Clinical Studies, Self-Testing. Establish concordance between the CPK Now the spectrophotometric assay using CPK patient samples from 3 clinical sites; at the University of Pittsburgh Children’s Hospital (UPMC), University of California, Los Angeles (UCLA), and Mount Sinai, New York.