Scientific Team / Validations
What is the main responsibility of the APH Scientific Team at the LA site?
Assay development and validation
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What are LDTs and how do they differ from IVD kits?
Lab Developed Tests (LDTs) are created in-house, using commercial antibody concentrates, unlike IVD kits that are ready-to-use commercial products
Who approves all validations before the assay goes into production?
Dr. Yue
Aside from validation and Medical Director approval, what else needs to happen before assay can be used for patient testing?
Transfer of validated assay into production, including SOP creation and training of histotechnologists.
What are the key steps/activities for assay development and validation?
Validation plan, wet-lab experiments, pathologist reviews, and validation report.