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What steps are used in a New Assay Validation?

April 26, 2017assay steps Used validation

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What steps are used in a New Assay Validation?

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1. Confirm performance characteristics (i. precision, linearity and sensitivity). 2. Establish control ranges and acceptable CV. 3. Correlation study with existing method or with another site using the same method. 4. Validate published expected values or establish own normal range.