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Point of Care Testing Ned D Heindel Chemistry ndh0 lehigh edu What do these have in common And this thermometer And this And this And this And even this this THE Most Popular THESE ARE ALL POINT OF CARE POC ASSAY KITS Now Just What is Point of Care Answer Home bed side office WHY PERFORM POINT OF CARE 7 50 vs 55 20 careful here 1 minute response vs 24 hour response Therapy response can be instantly coupled to the measurement Patient sees consequences of action Patient can receive results confidentially WHAT S THE ROLE OF FDA IN POC DIAGNOSTICS How Does FDA View Pt of Care Will test results be used to alter patient therapy If so FDA approval needed Blood glucose Blood pressure Pregnancy Ovulation Will assay be sold overseas If in total FDA approval needed if in part not Ya Gotta Have a Specific BioMarker or POC Won t Work Beta HCG 244 amino acids 36 700 D made by embryo Other Bio markers Elevated glucose in urine or blood High Blood Pressure or Body Temperature Cardiac or liver enzymes ex organ Luteinizing Hormone And many many others some observational Ferning Fertility High Content Screening This is an insult to Chemists Guiacol Fertility Blood and Steve Klasko LU B A 74 OH OCH3 What Clinical Conditions do we Test for by POC Glucose Pregnancy ovulation sperm count ca 65 ca 12 FertilMARQ yes v no at 20M swimmers mL Cardiological assays ca 10 Coagulation Infectious Diseases a HIV b hepatitis c bladder infections Electrolytes Blood Gases Alcohol Intoxication Heart Attack Rupture of Liver Cells Impaired Metabolism of Multi Drug Prescriptions Saladax How do We Get Specificity A Specific Chromatographic Migration Enzymatic Recognition Immuno Recognition Electrochemical Reduction Electrochem Specificity Pharmaceutical Examples DRUG e DRUG at precise potential Misonidazole Clotrimazole Streptozotocin Ritonavir 0 64 v 0 19 v 1 34 v 1 91 v Precise potential for reduction identifies the drug total current flow measures the amount What are the Justifications Most are obvious a few not so Monitoring anticancer drug metabolism at home or at lab Challenges in Configuring the Assay What should we sample Yes vs No cut off assay or precise measurement assay Simplicity of Use the blue line rushes past Checks and balances air water sun decomp of reagents stabilizing reagents Handling confirmation of serious finding Handling Reagents CONSTRUCTING AN ASSAY with MAb heavy chains yellow light blue light chains green dark blue carbohydrate red CONSTRUCTING AN ASSAY MAb tag analyte MAb tag analyte then Anti MAb to MAb tag analyte grabs holds this combo in a narrow target zone Visual tag not bound covalently can be released by the binding event Assembling the Assay What Can Go Wrong Untrained assayer Test is inherently less accurate Community medicine misses a community trend Insurance seldom covers point ofcare A FEW FAMOUS FAILURES Toilet paper fecal blood test Fecal sampling spoon and rubbing paper Ejaculate on bulls eye and microwave Heated patch for sweat sampling Home use ferning assay with scope WHAT s THE FUTURE A bright future for R D and investment where chemistry biology medicine meet Possible cost savings to the patient For now a few tests do appear to cost more per test Major increase in medical effectiveness Confidentiality and increased patient responsibility for personal health Let s Look at it as a Business Time to market for a diagnostic 3 5 yr Time to market for a drug 9 2 yr ROI per year for diagnostic ca 8 5 ROI per year for a drug ca 18 Legal protection for a diagnostic ca 65K year product Legal protection for a drug 150K yr product Better things for better living through CHEMISTRY http www craigmedical com

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