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Molecular Diagnostics and Laboratory Accreditation

- Week 25: Molecular diagnostics - LECTURE 1 - Accreditation in laboratories and quality management - Validation: ensures that reagents and equipment perform as required, ensures consistency between implementations or test platforms - Verif i cation: a cross examination that a diagnostic test produces identical result to a known standard - 'GxP' refers to the various good practices regulated - Applicable to clinical trials, Enforces tight guidelines on: ethical aspects, comprehensive documentation for the clinical protocol, record keeping, training facilities, Data handling (including computers and software - For cytogenetics you need cells in mitosis - they need to be cultured - Analysis: - Flow cytometry: side and forward scatter - HER2 in breast cancer: Crosstalk between HER family tyrosine kinase receptors and cell signalling - TNM staging Extraction of DNA (and RNA) from FFPE samples U 0 Paraffin removal Sample lysis DNA decrosslinking 0 0 DNA binding DNA washing DNA elution - LECTURE 2: FSH - Fluorescent in situ hybridisation