Core E Immunoglobulin E Analysis Core

核心E的目的是为项目1和2提供高质量的总IgE和过敏原特异性IgE分析 来自获得临床免疫球蛋白E分析认证的实验室，因为每个参与者的分析结果将 与参与者共享。在从项目1的大队列中招募妇女期间 参与项目2的IgE分析将需要在以成本获得样本后不久进行- 高效的方式。自奥古斯塔大学儿科变态反应免疫实验室开展临床IgE以来 几乎每天都在进行分析，快速报告受试者样本不会有任何困难。一个 将建立会计制度，在临床和研究样本之间按比例分配试剂成本，但 所有的分析都将按照相同的高标准进行。实验室保持CLIA-认证 并参与了美国病理学家学会(CAP)的IgE质量保证计划 测试。实验室已经为WHEALS队列进行了所有的IgE分析，并为 当前计划项目P01拨款。重复测定的变异系数始终在 6%或更低。为了确保数据质量，1%的样本在几周或几个月后重新分析，并与 原始结果。亨利·福特健康系统为这项研究送来的所有样本都将采用条形码，如下所示 过去的事。这允许在运输和分析过程中对样品进行一致的跟踪。示例条形码是 当样品被打包准备发货时扫描，发货清单通过安全加密的电子邮件发送。这个 样品条形码在收到后立即扫描，并与发货清单匹配 实验室。条形码没有显示个人数据，所以实验室完全看不到名字和 捐献样本的受试者的身份。来自Pharmacia UniCAP仪器的数据直接发送到 亨利福特健康系统的生物统计核心B使用相同的条形码识别号。这 在过去的10年里，这一系统运行良好。在转移过程中没有样品丢失，结果很容易得到 上传到研究数据库中进行分析。奥恩比博士将监督IgE检测的表现。

The purpose of Core E is to provide high quality analyses of total and allergen specific IgE for Projects 1 and 2 from a laboratory appropriately certified for clinical IgE analyses, since results of each participant's analysis will be shared with the participant. During the recruitment of women from the large cohort in Project 1 for participation in Project 2 IgE analyses will need to be performed soon after the sample is obtained in a cost- efficient manner. Since the Augusta University Pediatric Allergy-Immunology Laboratory performs clinical IgE analyses on an almost daily basis there will be no difficulty with rapid reporting of the subject samples. An accounting system will be set up to proportion the costs of reagents between clinical and research samples but all analyses will be performed to the same high clinical standards. The laboratory maintains CLIA-certification and participates in the quality assurance program of the College of American Pathologists (CAP) for IgE testing. The laboratory has performed all IgE analyses for the WHEALS cohort and all IgE analyses for the current program project P01 grant. The coefficients of variation for repeat assays are consistently in the range of 6% or less. To assure data quality 1% of samples are reanalyzed weeks or months later and compared to the original results. All samples sent from Henry Ford Health System for this research will be bar-coded as in the past. This allows consistent tracking of samples during shipment and analysis. Sample bar codes are scanned as samples are packed for shipment and the shipping list is sent via secure encrypted email. The sample bar codes are immediately scanned and computer matched to the shipping list upon receipt in the laboratory. The bar coding reveals no personal data so the laboratory is completely blinded to the name and status of the subject who donated the sample. Data from the Pharmacia UniCAP instrument is sent directly to the Biostatistics Core B at Henry Ford Health System using the same bar-coded identification number. This system has worked well for the past 10 years. No samples have been lost during transfer and results are easily uploaded into the study database for analyses. Dr. Ownby will oversee the performance of the IgE testing.