BLOOD AND URINE SAMPLING FOR QC AND QA PROCEDURES FOR GCRC CORE LABORATORY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 核心实验室为GCRC研究者提供分析服务，我们必须有一个机制来监测我们分析的可靠性。临床实验室的常见做法是使用有限数量正常受试者的血液样本来记录由于特定试剂、试剂盒批次、采血管或测定方法的变化而导致的可测量分析物值的变化。此外，尽管建立分析物参考范围超出了我们的资源范围，但从有限数量的正常受试者中采集的血液可用于验证检测试剂盒制造商提供的参考范围。 这些研究将确定在GCRC核心实验室内运行的测定是否以分析合理和可靠的方式进行。从有限数量的正常受试者（n = 20）中采集的血液样本将确定可测量值是否因试剂、试剂盒批次、试管类型或测定方法的变化而发生显著（>10%）变化。从正常受试者中采集的血液将用于验证参考范围，方法是确定20例受试者的平均值是否在试剂盒生产商确定的95%区间内。更具体地说，如果我们的正常人群的平均值福尔斯落在95%区间之外，我们对该检验的有效参考区间的假设将受到质疑，并将启动进一步的调查。研究人群将包括健康男性和女性成年人（18-65岁）。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Core Lab provides assay services to GCRC investigators, and it is essential that we have a mechanism to monitor the reliability of our assays. It is common clinical laboratory practice to use blood samples from a limited number of normal subjects to document shifts in measurable analyte values due to change in specific reagents, kit lot, blood collection tubes or assay method. Also, although it is beyond the scope of our resources to establish analyte reference ranges, blood collected from a limited number of normal subjects can be used to verify reference ranges provided by assay manufacturers. These studies will determine whether assays run within the GCRC Core Lab perform in an analytically sound and reliable manner. Blood samples collected from a limited number of normal subjects (n = 20) will determine whether significant (>10%) shifts in measurable values occur due to changes in reagent, kit lot, tube type or change in assay methodology. Blood collected from normal subjects will be used to verify reference ranges, by determining whether mean values from 20 subjects fall within the 95% interval established by the kit manufacturer. More specifically, if the mean of our normal population falls outside of the 95% interval, the hypothesis that we have a valid reference interval for that test will be questioned and further investigation will be initiated. The study population will include healthy male and female adults (18-65 years of age).