Central Biochemistry Laboratory of the CKiD Consortium

描述（由申请人提供）： 中央生物化学实验室 (CBL) 在儿童慢性肾脏病前瞻性研究 (CKiD) 的更新中发挥了关键的领导作用。 CBL 负责向参与临床中心提供进行基于碘海醇的肾小球滤过率 (GFR) 研究所需的试剂、用品、运输商和方案，并将血液运送到罗切斯特大学实验室分析关键的肾脏决定因素，包括 Cr、BUN、电解质、葡萄糖、Ca、P、完整 PTH、维生素 D、CRP、血脂筛查和胱抑素 C。同样，收集和运输尿液中的蛋白质、肌酐和微量白蛋白以评估其性质肾脏损害。 CBL 还向所有参与地点提供试剂、托运商和说明，以便向 NIH 存储库提交血液、血浆、血清、尿液、头发和指甲样本。 CBL 与临床协调中心合作，为每个参与中心的协调员和研究人员提供培训、有关每次研究访问的进行的信息和指导、生化方法的专业知识以及这些分析的临床解释。 CBL 与数据协调中心 (DCC) 合作，优化 GFR 研究，更好地了解慢性肾脏病的进展，提供与流行病学预测的临床相关性，建立所有检测的质量控制，并生成新公式以在未进行碘海醇研究时评估就诊期间的 GFR。 CBL 定期参加指导委员会会议和电话会议以及摘要、演示文稿和手稿的生成，以便为 CKiD 研究的成功做出贡献并记录下来。 CBL 在 CKiD 研究中的努力总结为五个具体目标。一是继续提供准确、精准、高效的措施 基于碘海醇的 GFR，因为它是衡量生长的关键自变量， 检查心血管疾病和神经认知。其次，在具有适当质量控制的许可临床实验室中利用生化检测，继续提供对一般肾脏健康状况的准确和精确的测量。第三，与 DCC 密切合作，提供 GFR 的准确估计，并在未执行碘海醇 GFR 时确定就诊期间 GFR 随时间的变化。第四，继续改进和简化基于碘海醇的 GFR 测量，以维持 CKiD 受试者的招募和保留。第五，继续向参与临床中心提供样本采集和处理的实验室试剂盒，每天准确接收、处理和分析这些样本，并及时将数据输入CKiD网络数据库，供参与临床中心、临床协调中心和数据协调中心访问。长期目标是提供准确的分析来表征 CKiD 人群并维持 CKiD 受试者的招募和保留。

DESCRIPTION (provided by applicant): The Central Biochemistry Laboratory (CBL) has assumed a key leadership position in the renewal of the Prospective Study of Chronic Kidney Disease in Children (CKiD). The CBL is responsible for providing participating clinical sites with the reagents, supplies, shippers and protocols needed for performing iohexol based glomerular filtration rate (GFR) studies and transporting blood to the University of Rochester laboratory for analysis of key kidney determinants, including Cr, BUN, electrolytes, glucose, Ca, P, intact PTH, vitamin D, CRP, lipid screen, and cystatin C. Similarly, urine is collected and transported for protein, creatinine, and microalbumin to assess the nature of kidney damage. The CBL also provides reagents, shippers, and instructions to all participating sites for submission of blood, plasma, sera, urine, hair and nail samples to NIH repositories. In conjunction with the Clinical Coordinating Centers, the CBL provides training of coordinators and investigators of each participating site, information and instruction concerning the conduct of each study visit, expertise in the biochemical methodology and clinical interpretation of these analyses. The CBL collaborates with the Data Coordinating Center (DCC) to optimize the GFR studies, better understand the progression of chronic kidney disease, provide clinical correlation with epidemiological projections, establish quality control of all assays, and generate new formulas to estimate GFR during visits when an iohexol study is not performed. The CBL regularly participates at Steering Committee meetings and conference calls as well as in the generation of abstracts, presentations, and manuscripts in order to contribute to and document the success of the CKiD study. The CBL's effort in the CKiD study is summarized in five specific aims. First, continue to provide accurate, precise, and most efficient measures of iohexol-based GFR, because it is the key independent variable against which measures of growth, cardiovascular disease, and neurocognition are examined. Second, continue to provide accurate and precise measurements of general kidney health status, utilizing biochemical assays in a licensed clinical laboratory with appropriate quality controls. Third, work closely with the DCC to provide accurate estimates of GFR and determine time-dependent changes in GFR during visits when iohexol GFR is not performed. Fourth, continue to improve and streamline the iohexol-based GFR measurement to maintain recruitment and retention of CKiD subjects. Fifth, continue to provide to the participating clinical sites laboratory kits for the collection and handling of samples, accurately receive, process, and analyze these samples on a daily basis, and provide timely data entry into the CKiD web-based data base for access by the participating clinical sites, Clinical Coordinating Centers, and Data Coordinating Center. The long term goal is to provide accurate assays to characterize the CKiD population and maintain recruitment and retention of CKiD subjects.