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）为儿童慢性肾脏疾病（CKiD）持续前瞻性研究的受试者和研究者提供服务。CBL为参与的临床站点提供方案、试剂盒、试剂、用品和运输，以进行基于碘hexol的肾小球滤过率（GFR）研究，并收集血液和尿液供URMC和其他实验室分析。血液分析包括电解质、尿素氮、肌酐、葡萄糖、钙、磷、白蛋白、尿酸、脂质筛选、hsCRP、完整甲状旁腺素和胱抑素c。尿液分析包括肌酐、蛋白质和微量白蛋白。CBL已经确定了运输这些分析物的最佳条件，并为每次访问提供环境托运人，并为冷冻标本提供季度干冰托运人。CBL还提供收集和运送血液、血浆、血清、尿液、头发和指甲样本到NIH知识库的试剂盒和说明。每次CKiD访问的生化数据都会被审查并输入到CKiD数据库Nephron中。CBL在CKID年度会议上提供培训，并随时在CKID访问期间根据现场协调员的需要提供信息、指导和支持。CBL在进行生化分析和结果的临床解释方面提供专业知识。CBL定期与数据协调中心（DCC）合作，优化GFR研究并构建在奇数次访问期间使用的GFR估计方程，其中不进行碘醇研究，维护程序手册，确保所有分析的质量控制，并通过更换仪器提供生化分析的连续性。CBL参与所有指导委员会会议和电话会议，并与研究人员合作撰写摘要、报告和手稿，进一步证明CKiD研究的成功。CBL的目标是继续提供准确、精确和有效的基于碘醇的GFR测量和一般肾脏健康的生化测量。在这一周期中，一项初步研究将继续确定手指穿刺样本是否可以代替血清采集碘醇GFR。我们计划开发更好的GFR估计方程，特别是对于队列2的儿童，他们的GFR水平高于队列1的儿童。CBL已经提交了概念表，以进一步确定高尿酸血症是否预测肾脏进展或高血压，微量白蛋白尿是否比尿蛋白更好地预测肾脏进展，并检查微量β蛋白以确定其是否有助于预测GFR。最后，CBL将继续向参与站点提供受试者和特定访问的实验室试剂盒，用于样品的收集、处理和运输，以及每天接收、处理和分析这些样品，并及时向Nephron提供数据输入。长期目标是更好地描述CKiD种群的生化特征，保持数据的完整性，并以保持CKiD受试者的招募和保留的方式优化标本收集。

DESCRIPTION (provided by applicant): The Central Biochemistry Laboratory (CBL) serves the subjects and investigators of the continuing Prospective Study of Chronic Kidney Disease in Children (CKiD). The CBL provides participating clinical sites with protocols, kits, reagents, supplies, and transportation required for performing iohexol-based glomerular filtration rate (GFR) studies and collecting blood and urine for analysis at URMC and other laboratories. Blood analytes include electrolytes, BUN, creatinine, glucose, calcium, phosphorus, albumin, uric acid, lipid screen, hsCRP, intact PTH, and cystatin C. Urine analytes include creatinine, protein, and microalbumin. The CBL has determined optimal conditions for transporting these analytes, and provides ambient shippers for each visit and quarterly dry ice shippers for frozen specimens. The CBL also provides the kits and instructions for collection and shipment of blood, plasma, sera, urine, hair, and nail samples to NIH repositories. Biochemical data from each CKiD visit are reviewed and entered into Nephron, the CKiD data base. The CBL provides training at annual CKID meetings and is readily available to provide information, instruction, and support during CKiD visits, as needed by the site coordinators. The CBL contributes expertise in performing biochemical assays and clinical interpretation of the results. The CBL collaborates regularly with the Data Coordinating Center (DCC) to optimize GFR studies and to construct GFR estimating equations used during odd number visits at which no iohexol study is performed, maintain the Manual of Procedures, assure the quality control of all assays, and provide continuity of biochemical assays through changes in instrumentation. The CBL participates in all Steering Committee meetings and conference calls and collaborates with investigators in the generation of abstracts, presentations, and manuscripts, which further document the success of the CKiD study. The aims of the CBL center on continuing to provide accurate, precise, and efficient measures of iohexol-based GFR and biochemical measurements of general kidney health. A pilot study to determine if fingerprick samples can replace serum collections for the iohexol GFR continues during this cycle. We plan to develop better GFR estimating equations, particularly for the children of Cohort 2, who have higher levels of GFR than those of Cohort 1. The CBL has submitted concept sheets to further determine if hyperuricemia predicts renal progression or hypertension, if microalbuminuria is a better predictor of renal progression than urinary protein, and to examine beta trace protein to determine if it is useful in predicting GFR. Finally, the CBL will continue to provide to the participating sites subject- and visit specific- laboratory kits for the collection, handling, and transport of samples, as well as receive, process, and analyze these samples on a daily basis, and provide timely data entry into Nephron. The long term goal is to better characterize the CKiD population biochemically, maintain the integrity of the data, and to optimize the collection of specimens in a manner that maintains recruitment and retention of CKiD subjects.