Specifically, the contractor will: 1. Develop and refine Luminex universal DNA array assays to detect mutations associated with the following disorders: galactosemia, biotinidase deficiency, MCADD, hearing loss due to connexin-26 mutations or cytomegalovirus virus. 2. Develop xMAP assays by applying multiplex immunoassay techniques to test for the following conditions: congenital hypothyroidism, congenital adrenal hyperplasia. cystic fibrosis, Krabbe disease and other leukodystrophies. Assays will consist of multiple markers for each condition. When each assay is optimized. they will be combined into a single multiplexed assay. 3. Evaluate and validate each protocol using unidentified samples from the New York State Newborn Screening Program and the quality control (QC) materials from the Centers for Disease Control and Prevention National Newborn Screening Quality Assurance Program; 4. Evaluate and validate each protocol using fully characterized newborn samples tied to complete. 1 a year medical histories from the Newborn Screening Program of the Statens Serum Institute;
