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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

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