Division Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA.
Alzheimers Dement. 2013 Mar;9(2):137-40. doi: 10.1016/j.jalz.2012.11.003. Epub 2012 Dec 28.
Recognizing that international collaboration is critical for the acceleration of biomarker standardization efforts and the efficient development of improved diagnosis and therapy, the Alzheimer's Association created the Global Biomarkers Standardization Consortium (GBSC) in 2010. The consortium brings together representatives of academic centers, industry, and the regulatory community with the common goal of developing internationally accepted common reference standards and reference methods for the assessment of cerebrospinal fluid (CSF) amyloid β42 (Aβ42) and tau biomarkers. Such standards are essential to ensure that analytical measurements are reproducible and consistent across multiple laboratories and across multiple kit manufacturers. Analytical harmonization for CSF Aβ42 and tau will help reduce confusion in the AD community regarding the absolute values associated with the clinical interpretation of CSF biomarker results and enable worldwide comparison of CSF biomarker results across AD clinical studies.
认识到国际合作对于加速生物标志物标准化工作以及改进诊断和治疗的效率至关重要，阿尔茨海默病协会于 2010 年创建了全球生物标志物标准化联盟（GBSC）。该联盟汇集了学术中心、行业和监管界的代表，共同目标是为评估脑脊液（CSF）中的淀粉样蛋白β42（Aβ42）和 tau 生物标志物制定国际公认的通用参考标准和参考方法。这些标准对于确保分析测量在多个实验室和多个试剂盒制造商之间具有可重复性和一致性至关重要。CSF Aβ42 和 tau 的分析协调将有助于减少 AD 领域对与 CSF 生物标志物结果临床解释相关的绝对值的困惑，并能够在全球范围内对 AD 临床试验中的 CSF 生物标志物结果进行比较。
