Core - Biomarker Reference Laboratory (BRL)

核心 - 生物标志物参考实验室 (BRL)

• 批准号: 10705806
• 负责人: JAMES G. HERMAN
• 金额: $ 19.77万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705806
• 关键词: Address; Baltimore; Benign; Biological Assay; Biological Markers; Biopsy; Blinded; Body Fluids; CLIA certified; Cancer Etiology; Categories; Cells; Cessation of life; Characteristics; Clinical; Collaborations; DNA Methylation; Detection; Development; Diagnostic Procedure; Diameter; Disease; Early Detection Research Network; Early Diagnosis; Ensure; Evaluation; Exhibits; Funding; Healthcare; Image; Knowledge; Laboratories; Lesion; Longterm Follow-up; Lung; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of lung; Maryland; Methodology; Methods; Methylation; Morbidity - disease rate; Nodule; Operative Surgical Procedures; Participant; Patients; Performance; Plasma; Population; Predictive Value; Procedures; Quality Control; Reagent; Reproducibility; Research Personnel; Sampling; Screening Result; Specificity; Standardization; Technology; Testing; Time; Universities; Validation; arm; assay development; biomarker development; biomarker validation; candidate marker; experience; flexibility; laboratory development; liquid biopsy; lung cancer screening; methylation biomarker; mortality; multidisciplinary; prospective; sample collection; screening; wasting

The Biomarker Reference Laboratory (BRL) will be led by Dr. Sanford Stass and as a component of the BCC will develop, refine, and standardize the biomarkers assays developed by the Biomarker Development Laboratory. This BRL is a continuation of the University of Maryland Baltimore Biomarker Reference Laboratory. UMB-BRL has for the past 15 years provided active support of the EDRN, including testing of candidate biomarkers, development of assays and technologies, and standardization of assay methods in collaboration with multiple investigators in the EDRN. The proposed BRL includes a multi-disciplinary team of directors/co- investigators and staff with broad knowledge, experience and expertise in application of technology for biomarkers including reagent and assay development and implementation, validation of laboratory methodology and assays, quality control for reagents and technologies, evaluation of accuracy, precision, reproducibility and characteristics of performance including sensitivity, specificity, and positive and negative predictive values. The BRL will bring DNA methylation biomarkers from the BDL into a CLIA compliant laboratory using developed standard operating procedures (SOPs), and extensive experience in collaborative studies in biomarker validation.

生物标志物参考实验室（BRL）将由Sanford Stass博士领导， BCC的一个组成部分将开发、完善和标准化所开发的生物标志物检测方法 生物标志物开发实验室这BRL是一个延续的大学 马里兰州巴尔的摩生物标志物参考实验室。UMB-BRL在过去的15年里 为EDRN提供了积极的支持，包括候选生物标志物的测试， 分析和技术，以及与多个合作的分析方法的标准化 EDRN的调查员。拟议的BRL包括一个多学科的董事/联席团队， 调查人员和工作人员在应用 生物标志物技术，包括试剂和检测开发和实施， 验证实验室方法和分析，试剂和技术的质量控制， 准确度、精密度、重现性和性能特征评价，包括 灵敏度、特异性以及阳性和阴性预测值。BRL会把DNA 将来自BDL的甲基化生物标志物转移到符合CLIA标准的实验室， 标准操作规程（SOP），以及在以下领域的合作研究方面的丰富经验： 生物标志物验证。