Central Biochemistry Laboratory of the CKiD Consortium

描述（由申请方提供）：中心生化实验室（CBL）为儿童慢性肾脏病（CKiD）持续前瞻性研究的受试者和研究者提供服务。CBL为参与的临床研究中心提供进行基于碘海醇的肾小球滤过率（GFR）研究以及采集血液和尿液用于URMC和其他实验室分析所需的方案、试剂盒、试剂、用品和运输。血液分析物包括电解质、BUN、肌酐、葡萄糖、钙、磷、白蛋白、尿酸、脂质筛查、hsCRP、完整PTH和胱抑素C。尿液分析物包括肌酸酐、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，并为每次访视提供了常温运输箱，为冷冻标本提供了季度干冰运输箱。CBL还提供了血液、血浆、血清、尿液、毛发和指甲样本的采集和运输到NIH储存库的试剂盒和说明。审查每次CKiD访视的生化数据，并将其输入到CKiD数据库Nephron中。CBL在年度CKID会议上提供培训，并在CKiD访问期间随时提供研究中心协调员需要的信息、指导和支持。CBL在进行生化分析和临床结果解释方面提供专业知识。CBL定期与数据协调中心（DCC）合作，以优化GFR研究，并构建在奇数次访视（未进行碘海醇研究）期间使用的GFR估计方程，维护程序手册，确保所有测定的质量控制，并通过仪器变更提供生化测定的连续性。CBL参与所有指导委员会会议和电话会议，并与研究者合作生成摘要，演示文稿和手稿，进一步记录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海醇的GFR测量和一般肾脏健康的生化测量。在此周期内继续进行一项试点研究，以确定手指针刺样本是否可以取代碘海醇GFR的血清采集。我们计划开发更好的GFR估计方程，特别是对于GFR水平高于队列1的队列2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，微量白蛋白尿是否是比尿蛋白更好的肾脏进展预测因子，并检查β痕量蛋白以确定其是否可用于预测GFR。最后，CBL将继续向参与研究中心提供受试者和访视特定的实验室试剂盒，用于样本的采集、处理和运输，以及每天接收、处理和分析这些样本，并及时将数据录入Nephron。长期目标是更好地表征CKiD人群的生物化学特征，保持数据的完整性，并以保持招募和保留CKiD受试者的方式优化标本采集。

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.