DIGITAL SINGLE-USE FREE AND TOTAL PSA RAPID TEST

数字一次性免费总 PSA 快速测试

• 批准号: 2422975
• 负责人: JOEL M BLATT
• 金额: $ 10万
• 依托单位: METRIKA LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 1998-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2422975
• 关键词: biomedical equipment development; blood chemistry; clinical biomedical equipment; diagnosis design /evaluation; early diagnosis; electronic recording system; immunochemistry; immunologic assay /test; neoplasm /cancer immunodiagnosis; optics; prostate neoplasms; prostate specific antigen; rapid diagnosis

Prostate cancer causes about 40,000 deaths per year in the United States and is the second highest cause of cancer death among males. Each year, there are over 300,000 new cases of this disease. A key goal in diagnosis of cancer is early detection which allows physicians to intervene at a time when tumor growth is at an early stage. A rapid and inexpensive biochemical test for prostate cancer (provided by Metrika's device), in conjunction with digital rectal examination, will greatly assist the physician in providing a diagnosis while the patient is still in the office, and can provide timely feedback on the effectiveness of treatment and on the detection of recurrence. Measurement of both free and total levels of prostate specific antigen (PSA) will help to distinguish malignancy from benign prostatic hyperplasia (BPH). Metrika laboratories will develop the Digital Response Free/Total PSA Rapid Test which is a rapid, single-use, disposable assay based on the simultaneous measurement of both classes of PSA in a serum, plasma or whole blood sample to yield quantitative numerical results. The test device, which will be about the size of a credit card, will combine inexpensive microelectronics and dry reagent immunochemistry. The focus of this proposal is on demonstrating the feasibility of the dry reagent immunoassays and their integration into a breadboard device. This innovative test will be inexpensive, extremely simple to operate and will provide a digital display of results in a few minutes. This technology will benefit physicians and the healthcare system by improving the efficiency of healthcare delivery at the point of care. In addition, patients will not be subject to return office visits, requiring lost time from work and other expenses, and will receive immediate feedback on their status with respect to this highly prevalent form of cancer. PROPOSED COMMERCIAL APPLICATION: The commercial applications of the Digital Response Free/Total PSA Rapid Test are in point of care sites where access to a rapid quantitative analysis is limited or non-existent. Urologists and primary care physicians will initiate and control use of the test which will yield significant economic and patient benefits.

前列腺癌在美国每年导致约40，000人死亡 是男性癌症死亡的第二大原因。 每年， 有超过30万的新病例 诊断的关键目标 癌症的早期发现，这使得医生可以在一个 肿瘤生长处于早期阶段。 一个快速和廉价的 前列腺癌的生化测试（由Metrika的设备提供）， 结合直肠指诊，将大大有助于 医生在提供诊断，而病人仍然在 办公室，并能及时反馈治疗效果 以及对复发的检测。 自由和总量的计量 前列腺特异性抗原（PSA）水平将有助于区分 良性前列腺增生（BPH）引起的恶性肿瘤。 Metrika实验室将开发数字响应免费/总PSA 快速检测是一种快速、一次性使用的检测方法，基于 同时测量血清、血浆或血浆中的两类PSA， 全血样本，以产生定量数值结果。 测试 一个大约信用卡大小的设备，将联合收割机 廉价微电子学和干试剂免疫化学。 重点 该方案的主要目的是论证干试剂的可行性， 免疫测定及其集成到试验板装置中。 这种创新的测试将是廉价的，操作非常简单， 将在几分钟内提供结果的数字显示。 这 技术将使医生和医疗保健系统受益， 在护理点提供医疗服务的效率。 此外，本发明还提供了一种方法， 患者将不需要返回办公室就诊，需要损失时间 从工作和其他费用，并将收到他们的即时反馈， 关于这种高度流行的癌症形式的状态。 建议的商业应用： 数字响应免费/总PSA快速测试是在护理点 其中获得快速定量分析的途径有限或不存在。 泌尿科医生和初级保健医生将启动和控制使用 该测试将产生显著的经济和患者效益。