Core E Immunoglobulin E Analysis Core

核心 E 免疫球蛋白 E 分析核心

• 批准号: 10480073
• 负责人: Dennis R Ownby
• 金额: $ 36.55万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-06 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10480073
• 关键词: Accounting; Allergens; American; Antibodies; Bar Codes; Biological Assay; Biostatistics Core; Blinded; Caring; Certification; Childhood; Clinical; Clinical Research; Communication; Computer software; Computers; Containment; Core Facility; Custom; Data; Databases; Dry Ice; Electronic Mail; Enzyme-Linked Immunosorbent Assay; Equilibrium; Equipment; Extrinsic asthma; Freezing; Future; Grant; Hazardous Substances; Health system; Human; Hypersensitivity; IgE; Immunology; Individual; Laboratories; Methods; Minor; Names; Participant; Pathologist; Performance; Personal Computers; Procedures; Protocols documentation; Reader; Reagent; Reporting; Research; Research Personnel; Resources; Sampling; Scanning; Secure; Serum; Shipping; Ships; System; Testing; Time; Training; Universities; Variant; Woman; Work; cohort; college; cost; cost efficient; data quality; encryption; experience; individualized prevention; instrument; medical schools; microbiota; pediatric department; preservation; programs; quality assurance; recruit; research study; square foot; systems research

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.

核心E的目的是为项目1和2提供总体和过敏原IGE的高质量分析 从适当认证的临床IGE分析的实验室，因为每个参与者的分析结果将 与参与者分享。在项目1的大型队列中招募妇女期间 在成本中获得样本后，需要进行项目2 IGE分析，需要进行。 有效的方式。自奥古斯塔大学小儿过敏 - 免疫学实验室以来 几乎每天进行分析，对受试者样本的快速报告将没有任何困难。一个 会计系统将设置为临床和研究样本之间的试剂成本的比例，但是 所有分析将符合相同的高临床标准。实验室维持CLIA认证 并参加IGE的美国病理学家学院（CAP）的质量保证计划 测试。该实验室已经对Wheals队列进行了所有IGE分析，并进行了所有IGE分析 当前的计划项目P01赠款。重复测定的变异系数始终在该范围内 6％或更少。为了确保数据质量1％的样品在数周后重新分析，并与 原始结果。从亨利·福特卫生系统发送的所有样本以进行这项研究 过去。这允许在装运和分析过程中持续跟踪样品。样本条代码是 扫描作为样品包装以进行运输，并通过安全的加密电子邮件发送运输列表。这 采样条形码立即扫描，并在收到时与运输列表匹配 实验室。条形码没有显示个人数据，因此实验室对名称完全看不见 捐赠样本的主题的状态。 Pharmacia Unicap仪器的数据直接发送给 亨利·福特卫生系统的生物统计学核心B使用相同的条形码识别号。这 在过去的10年中，系统运行良好。在转移过程中没有丢失样本，结果很容易 上传到研究数据库进行分析。 Ownby博士将监督IGE测试的性能。