Sensitive and Specific Rapid Diagnostic Test for Acute and Chronic Pancreatitis

急慢性胰腺炎的灵敏且特异的快速诊断测试

• 批准号: 8391443
• 负责人: Raymond Houghton
• 金额: $ 18.24万
• 依托单位: INBIOS INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8391443
• 关键词: Abdominal Pain; Accident and Emergency department; Acute; Amylases; Antibodies; Bedside Testings; Biological Assay; Biological Markers; Blood; Caring; Chronic; Clinic; Clinical; Clinical Protocols; Colon Carcinoma; Computers; Cytoplasmic Granules; Detection; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Early Diagnosis; Enzyme-Linked Immunosorbent Assay; Enzymes; Evaluation; Failure; Foundations; Goals; Hormones; Human; Image; Immunologic Tests; Incidence; Inflammation; Inflammatory Bowel Diseases; Inpatients; Insulin; Lateral; Lipase; Malignant neoplasm of pancreas; Membrane Proteins; Monitor; Monoclonal Antibodies; Morbidity - disease rate; Mus; Oryctolagus cuniculus; Pancreas; Pancreatitis; Patients; Peptic Ulcer; Performance; Phase; Proteins; Publishing; Reagent; Sampling; Sensitivity and Specificity; Serum; Specificity; Symptoms; Testing; Trypsin; United States; Vertebral column; Work; X-Ray Computed Tomography; Zymogen Granules; acute pancreatitis; base; cGMP production; chronic pancreatitis; cost effective; diagnostic accuracy; disease natural history; gastrointestinal; improved; malignant stomach neoplasm; novel; point of care; primary care setting; statistics; tomography

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：非常常见的患者对腹痛的抱怨表明诊断胰腺炎。但是，胰腺炎可能很难诊断或 排除基于血液的测试，血清淀粉酶和脂肪酶表现出对急性胰腺炎的敏感性和特异性，并且对慢性胰腺炎的敏感性和特异性非常差。因此，胰腺炎经常无法诊断，直到发生相当大的发病率进行成像研究，例如计算机断层扫描，能够检测到结构性损害。因此，显然需要对胰腺炎进行更好的血液测试。为了开发一种新颖的胰腺炎测试，我们研究了Zymogen颗粒膜蛋白GP2作为急性和慢性胰腺炎的生物标志物，并开发了ELISA以在患者血清中检测。该项目的主要目的是进一步提高ELISA的性能，并为GP2开发快速的护理测试，以诊断急性或慢性胰腺炎。该提案的主要目标是1）确定将改善GP2 ELISA并构成强大护理快速测试的基础的单克隆抗体； 2）确定ELISA并快速测试将优化测试灵敏度和特异性的最佳材料和试剂。 ELISA将更简单地执行，并提供提高的测试准确性。快速护理测试将极大地促进急诊室，紧急护理诊所和全世界的初级保健环境中腹痛和胰腺炎的诊断评估。 公共卫生相关性：急性和慢性胰腺炎症是美国发病率明显的原因。当存在适当的临床症状时，目前已诊断出急性胰腺炎（经常腹痛）。血清淀粉酶和脂肪酶广泛用于诊断胰腺炎。但是，它们为慢性胰腺炎提供了次优的敏感性和特异性。需要对胰腺的更好基于血液的测试。在此应用中，我们讨论了Zymogen颗粒膜蛋白GP2作为急性和慢性胰腺炎的生物标志物的实用性。该项目的主要目的是为GP2开发快速的护理测试，该测试能够诊断出急性或慢性胰腺炎。快速护理测试将极大地促进急诊室，紧急护理诊所和全世界的初级保健环境中腹痛和胰腺炎的诊断评估。