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）：非常常见的腹痛患者主诉提示胰腺炎的诊断。然而，胰腺炎可能难以诊断或 排除，因为使用的基于血液的测试，血清淀粉酶和脂肪酶，显示出对急性胰腺炎的敏感性和特异性不理想，对慢性胰腺炎的敏感性和特异性非常差。因此，胰腺炎常常在发病率相当高并且影像学研究（例如计算机断层扫描）能够检测到结构损伤之后才得到诊断。因此，显然需要更好的基于血液的胰腺炎检测。为了开发一种新颖且可靠的胰腺炎检测方法，我们研究了酶原颗粒膜蛋白 GP2 作为急性和慢性胰腺炎的生物标志物，并开发了一种 ELISA 方法用于在患者血清中检测该蛋白。该项目的主要目标是进一步提高 ELISA 的性能，并开发一种快速的 GP2 护理点测试，从而能够诊断急性或慢性胰腺炎。该提案的主要目标是 1) 鉴定单克隆抗体，以改进 GP2 ELISA 并为强大的护理点快速检测奠定基础； 2) 确定 ELISA 和快速测试的最佳材料和试剂，以优化测试灵敏度和特异性。 ELISA 将更容易执行，并且将提供更高的测试准确性。快速护理点测试将极大地促进全世界急诊室、紧急护理诊所和初级保健机构对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较高的一个原因。目前，当出现适当的临床症状（通常是腹痛）时，即可诊断出急性胰腺炎。血清淀粉酶和脂肪酶广泛用于诊断胰腺炎；然而，它们对慢性胰腺炎的敏感性和特异性不佳。需要一种更好的基于血液的胰腺炎检测。在此应用中，我们讨论了酶原颗粒膜蛋白 GP2 作为急性和慢性胰腺炎生物标志物的用途。该项目的主要目标是开发一种快速的 GP2 护理点测试，以诊断急性或慢性胰腺炎。快速护理点测试将极大地促进全世界急诊室、紧急护理诊所和初级保健机构对腹痛和胰腺炎的诊断评估。