Assay Validation Methods Definitions and Terms（试验验证方法定义和术语）.pdf

Assay Validation Methods - Definitions and Terms Validation methods are completed to ensure that an analytical methodology is accurate, specific, reproducible and rugged over the specified range that a target analyte will be analyzed. Assay validation provides an assurance of reliability during normal use, and is sometime referred to as the process of providing documented evidence that the method does what it is intended to do. Assay Validation Levels and Steps Assay Optimization (pre -validation): Assay optimization and pre -validation are experiments that determine how a range of matrix and sample elements, as well as assay conditions, effect assay parameters and assay performance. These data, along with scientific judgment, set the acceptance criteria for the assay validation. It is important to establish acceptance criteria before executing the validation protocol. Assay Q ualification: Assay qualification is an experimental protocol that demonstrates that an accepted method will provide meaningful dat a for the specific conditions, matrix and samples that the procedure is intended for. Assay Qualification may not require validat ion of accuracy and reliability of the method (sensitivity), but merely verify the suitability of the protocol under actual conditions (generally, specificity). Assay Validation : Comprehensive experiments that evaluate and document the quantitative performance of an assay, including sensitivity, specificity, accuracy, precision, detection limit, range and limits of quantitation. Full Assay Validation will include inter-assay and inter-laboratory assessment of assay repeatability and robustness. Assay Parameters DEFINITIONS Specificity is the ability to assess unequivocally the target pathogen or analyte in the presence of components which might be expected to be present (3). The specificity of an assay is the capability of the assay to differentiate similar organisms or analytes or other