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.
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