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 来自经过适当认证的临床IgE分析实验室，因为每个参与者的分析结果将 与参与者分享。在从项目1的大批妇女中招募妇女， 参与项目2 IgE分析将需要在获得样本后立即进行，费用- 有效方式由于奥古斯塔大学儿科过敏免疫学实验室进行临床IgE 几乎每天都进行分析，快速报告受试者样本将不会有任何困难。一个 将建立会计制度，按比例分配临床和研究样本之间的试剂成本， 所有的分析都将按照同样高的临床标准进行。实验室保持CLIA认证 并参加了美国病理学家学院（CAP）的IgE质量保证计划 试验.实验室已对WHEALS组群进行了所有IgE分析，并对WHEALS组群进行了所有IgE分析。 当前项目P01赠款。重复测定的变异系数始终在范围内 为确保数据质量，1%的样本在数周或数月后重新分析，并与 最初的结果。从亨利福特健康系统发送的用于本研究的所有样本将按照以下方式进行条形码编码： 过去这允许在运输和分析期间对样品进行一致的跟踪。示例条形码为 扫描样品包装发货，发货清单通过安全加密的电子邮件发送。的 样品条形码在收到后立即扫描，并通过计算机与装运清单进行匹配， 实验室条形码没有显示任何个人数据，因此实验室对姓名完全不知情， 捐献样本的受试者状态。Pharmacia UniCAP仪器的数据直接发送至 亨利福特卫生系统的生物统计核心B使用相同的条形码识别号。这 该系统在过去10年中运作良好。在转移过程中没有样品丢失，结果很容易 上传到研究数据库进行分析。Ownby博士将监督IgE检测的性能。

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.