DIGITAL SINGLE USE BONE RESORPTION RAPID TEST

数字化一次性骨吸收快速测试

• 批准号: 2006499
• 负责人: JOEL M BLATT
• 金额: $ 9.97万
• 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: 1997-05-05 至 1997-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2006499
• 关键词: biomarker; creatinine; diagnosis design /evaluation; digital imaging; immunologic assay /test; method development; musculoskeletal disorder diagnosis; osteoporosis; pathologic bone resorption; rapid diagnosis

Osteoporosis is a major worldwide public health problem with over 20 million individuals affected in the united states. Over 1.5 million fractures occur in the united states annually, resulting in 750,000 visits to the physician and long term hospitalization with a total impact to the health care system in excess of billion dollars. The current state-of-the-art in clinical diagnosis for Osteoporosis is bone density measurements which can be use neither to predict the onset of disease nor monitor the shot term effectiveness of therapy. At present, the only clinically useful diagnostic tolls for this purpose are microtitre plate immunoassays which are cumbersome to use and are available only in large clinical laboratories. Eyre and colleagues have identified and characterized the N- telopeptide cross-linking domain of type I collagen (NTx) as a highly specific marker for bone resorption. A microtitre plate immunoassay for this analyte has been commercialized by Ostex International, Inc., of Seattle, WA, and approved by the FDA. Metrika laboratories will develop the Digital Response NTx test which is a single-use, disposable, bone resorption assay based on the simultaneous measurement of the NTx bone specific marker and creatinine to yield a normalized quantitative result. The test device, which will be about the size of a credit card, will combine inexpensive microelectronics and dry reagent immunochemistry. This innovative test will be extremely simple to operate and will provide a digital display of results in a few minutes. The technology of Digital Response will benefit patients by providing a convenient and inexpensive method to monitor, at the point-of-care, the effectiveness of treatment to reduce accelerated bone loss in postmenopausal women.

骨质疏松症是一个主要的全球性公共卫生问题， 在美国有数百万人受到影响。 超过150万 美国每年发生骨折，导致75万人次就诊。 医生和长期住院治疗的总影响， 医疗保健系统超过10亿美元。 骨质疏松症临床诊断的最新技术水平是 骨密度测量既不能用来预测 也不能监测疾病的发作和治疗的短期有效性。 目前，用于此目的的唯一临床有用的诊断工具是 是使用麻烦的微量滴定板免疫测定， 仅在大型临床实验室中可用。 Eyre及其同事已经确定并表征了N- I型胶原的端肽交联结构域（NTx）作为一种高度 骨吸收的特异性标志物。 微量滴定板免疫分析法 用于该分析物的产品已经由Ostex International，Inc.， of西雅图，WA，并经FDA批准。 Metrika实验室将开发数字响应NTx测试， 是一种一次性使用的骨吸收测定法， 同时测量NTx骨特异性标志物， 肌酸酐以产生标准化的定量结果。 该测试装置， 它的大小和信用卡差不多，将联合收割机 微电子学和干试剂免疫化学。 这种创新的测试将是非常简单的操作和将 在几分钟内提供结果的数字显示。 技术 数字响应将通过提供方便和 一种廉价的方法来监测，在护理点， 减少绝经后妇女加速骨质流失的治疗 妇女

项目成果

A miniaturized, self-contained, single-use, disposable assay device for the quantitative determination of the bone resorption marker, NTx, in urine.

一种小型化、独立、一次性使用的检测装置，用于定量测定尿液中的骨吸收标记物 NTx。

• 发表时间: 1998
• 期刊: Clinical chemistry
• 影响因子: 9.3
• 作者: Blatt,JM;Allen,MP;Baddam,S;Chase,CL;Dasu,BN;Dickens,DM;Hardt,SJ;Hebert,RT;Hsu,YC;Kitazawa,CT;Li,SF;Mangan,WM;Patel,PJ;Pfeiffer,JW;Quiwa,NB;Scratch,MA;Widunas,JT
• 通讯作者: Widunas,JT