The very common patient complaint of abdominal pain suggests the diagnosis of pancreatitis. Pancreatitis, however, can be difficult to diagnose or rule out, as the blood-based tests used, serum amylase and lipase, demonstrate suboptimal sensitivity and specificity for acute pancreatitis, and very poor sensitivity and specificity for chronic pancreatitis. Thus pancreatitis often goes undiagnosed until after considerable morbidity has occurred and imaging studies, e.g., computer tomography, are able to detect structural damage. Therefore there is a clear need for a better blood-based test for pancreatitis. Towards developing a novel and robust test for pancreatitis, we have investigated the zymogen granule membrane protein, GP2, as a biomarker for acute and chronic pancreatitis and have developed an ELISA for its detection in patient serum. The major goal of this project is to further enhance the ELISA's performance and develop a rapid point of care test for GP2 that enables the diagnosis of acute or chronic pancreatitis. The major objectives of this proposal are to 1) identif monoclonal antibodies that will improve the GP2 ELISA and form the foundation of a robust point of care rapid test; and 2) determine for the ELISA and rapid test the best materials and reagents that will optimize the test sensitivity and specificity. The ELISA will be simpler to perform and will provide improved test accuracy. The rapid point of care test will greatly enable the diagnostic evaluation of abdominal pain and pancreatitis in emergency rooms, urgent care clinics and primary care settings throughout the world.
Public Health Relevance: Pancreatic inflammation, both acute and chronic, is a cause of significant morbidity in the United States. Acute pancreatitis is currently diagnosed when appropriate clinical symptoms are present (frequently abdominal pain). Serum amylase and lipase are widely used to diagnose pancreatitis; however, they offer suboptimal sensitivity and specificity for chronic pancreatitis. There is a need for a better blood-based test for pancreatiti. In this application, we have discussed the utility of zymogen granule membrane protein, GP2, as a biomarker for acute and chronic pancreatitis. The major goal of this project is to develop a rapid point of care test for GP2 that enables the diagnosis of acute or chronic pancreatitis. The rapid point of care test will greatly enable the diagnostic evaluation of abdominal pain and pancreatitis in emergency rooms, urgent care clinics and primary care settings throughout the world.
Public Health Relevance Statement: Pancreatic inflammation, both acute and chronic, is a cause of significant morbidity in the United States. Acute pancreatitis is currently diagnosed when appropriate clinical symptoms are present (frequently abdominal pain). Serum amylase and lipase are widely used to diagnose pancreatitis; however, they offer suboptimal sensitivity and specificity for chronic pancreatitis. There is a need for a better blood-based test for pancreatiti. In this application, we have discussed the utility of zymogen granule membrane protein, GP2, as a biomarker for acute and chronic pancreatitis. The major goal of this project is to develop a rapid point of care test for GP2 that enables the diagnosis of acute or chronic pancreatitis. The rapid point of care test will greatly enable the diagnostic evaluation of abdominal pain and pancreatitis in emergency rooms, urgent care clinics and primary care settings throughout the world.
NIH Spending Category: Cancer; Digestive Diseases; Pain Conditions - Chronic; Pain Research
Project Terms: Abdominal Pain; Accident and Emergency department; Acute; acute pancreatitis; Amylases; Antibodies; base; Bedside Testings; Biological Assay; Biological Markers; Blood; Caring; cGMP production; Chronic; chronic pancreatitis; Clinic; Clinical; Clinical Protocols; Colon Carcinoma; Computers; cost effective; Cytoplasmic Granules; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic; diagnostic accuracy; Diagnostic tests; disease natural history; Early Diagnosis; Enzyme-Linked Immunosorbent Assay; Enzymes; Evaluation; Failure (biologic function); Foundations; gastrointestinal; Goals; Hormones; Human; Image; Immunologic Tests; improved; Incidence; Inflammation; Inflammatory Bowel Diseases; Inpatients; Insulin; Lateral; Lipase; Malignant neoplasm of pancreas; malignant stomach neoplasm; Membrane Proteins; Monitor; Monoclonal Antibodies; Morbidity - disease rate; Mus; novel; Oryctolagus cuniculus; Pancreas; Pancreatitis; Patients; Peptic Ulcer; Performance; Phase; point of care; primary care setting; Proteins; Publishing; Reagent; Sampling; Sensitivity and Specificity; Serum; Specificity; statistics; Symptoms; Testing; tomography; Trypsin; United States; Vertebral column; Work; X-Ray Computed Tomography; Zymogen Granules
