Multiplex Serum panels for Osteoarthritis & Joint Injury

描述(申请人提供)：骨关节炎是老年人疼痛和残疾的最常见原因，由于缺乏良好的诊断测试，特别是对疾病的早期阶段，开发治疗方法是困难的。许多候选生物标志物处于不同的资格阶段。骨性关节炎倡议和几项临床试验提供了有限数量的珍贵、特征良好的血清和血浆样本。经过验证的多重免疫分析将最大限度地利用这些宝贵的样本。然而，目前，很少有高通量多重格式的骨关节炎相关生物标志物检测方法。该项目第一阶段的技术目标是开发高通量多路复用板，用于定量测量与骨关节炎和关节损伤相关的16个血清生物标志物。基于MSD的高灵敏度多阵列(R)电化学发光技术，将以96孔10点格式开发两块电池板。A组将包括多达10个低丰度标志物，并需要25微升的血清。B组将包括多达10个高丰度标记物，并将需要1微升血清。在分析验证后，将对有限数量的临床样本进行测试。在第二阶段， 我们将把检测范围扩大到大约40种，并从骨性关节炎临床试验中确定样本中的生物标记物浓度。 与公共卫生相关：骨关节炎是老年人疼痛和残疾的最常见原因，由于缺乏良好的诊断测试，特别是对疾病的早期阶段，开发治疗方法是困难的。这项提议的目标是 血液测试的发展，可以同时测量许多潜在有用的生物标志物。这将导致在治疗方案的早期确定治疗是否有效的更好的方法。

DESCRIPTION (provided by applicant): The development of a cure for osteoarthritis, the most common cause of pain and disability in the elderly, is difficult because of a lack of good diagnostics tests, in particular for early stages of the disease. Many candidate biomarkers are in various stages of qualification. Limited amounts of precious, well characterized serum and plasma samples are available from the Osteoarthritis Initiative and several clinical trials. Validated multiplexed immunoassays would make the best use of these precious samples. However, at present, few osteoarthritis-related biomarkers assays are available in a high-throughput multiplex format. The technical objective for Phase I of this project is the development of high throughput multiplex panels for the quantitative measurement of 16 serum biomarkers relevant for osteoarthritis and joint injury. Two panels will be developed in a 96-well 10-spot format based upon MSD's high-sensitivity MULTI-ARRAY(R) electrochemiluminescence technology. Panel A will include up to ten low abundance markers and will require 25 ul of serum. Panel B will include up to ten high abundance markers and will require 1 ul of serum. After an analytical verification, a limited number of clinical samples will be tested. In Phase II, we will expand the panels to approximately 40 assays and determine biomarker concentrations in samples from an osteoarthritis clinical trial. PUBLIC HEALTH RELEVANCE: The development of a cure for osteoarthritis, the most common cause of pain and disability in the elderly, is difficult because of a lack of good diagnostics tests, in particular for early stages of the disease. The objective of this proposal is the development of blood tests that measure many potentially useful biomarkers at the same time. This will lead to better ways to determine whether a treatment is effective earlier in the treatment regimen.