Multiplex Serum panels for Osteoarthritis & Joint Injury

描述（由申请人提供）：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，特别是在疾病的早期阶段，因此很难开发治疗骨关节炎的方法。许多候选生物标志物正处于不同的鉴定阶段。从骨关节炎倡议和几个临床试验中可以获得有限数量的珍贵的、特征明确的血清和血浆样本。经过验证的多重免疫分析将充分利用这些宝贵的样品。然而，目前，很少有骨关节炎相关的生物标志物分析是高通量的多重格式。该项目的第一阶段的技术目标是开发用于定量测量与骨关节炎和关节损伤相关的16种血清生物标志物的高通量多重面板。两个面板将基于MSD的高灵敏度MULTI-ARRAY(R)电化学发光技术，以96孔10点格式开发。A组将包括多达10个低丰度标记物，需要25 ul血清。B组将包括多达10个高丰度标记物，需要1 ul血清。经过分析验证后，将对有限数量的临床样本进行测试。在第二阶段，

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.