Guide in Validation of Alternative Proprietary （指导选择自营的验证）.pdfVIP

NordVal Protocol No. 2, Approved 26 May 2010 Guide in Validation of Alternative Proprietary Chemical Methods Contents DEFINITIONS2 PART 1: VALIDATION AND EVALUATION OF QUALITATIVE PROPRIETARY METHODS 5 A. METHOD COMPARISON STUDY 5 B. INTERMEDIATE STUDY9 C. INTERPRETATION9 PART 2: VALIDATION AND EVALUATION OF QUANTITATIVE PROPRIETARY METHODS 10 A. METHOD COMPARISON STUDY 10 B. INTERMEDIATE STUDY14 REFERENCES: 15 SCOPE This NordVal Protocol describes validation of proprietary chemical methods (test kits). The objective is to guide expert laboratories, NordVal technical committees and the NordVal steering group in the validation, evaluation and certification of test kits. This protocol consists of the following two parts, describing √ validation and evaluation of qualitative proprietary methods √ validation and evaluation of quantitative proprietary methods Preferably, the alternative method should be validated against a reference method. However, when no such method is available the validation can be carried out using certified reference materials, control materials and/or spiked samples at different levels in various matrixes. DEFINITIONS Accuracy, relative The relative accuracy is the degree of correspondence between the response obtained by the proprietary method and the reference method on artificially contaminated samples, or “the expected/true” results of the spiked samples. Analyte The analyte is the component demonstrated or measured by the method of analysis. Intermediate study A study of the proprietary method’s performance by at least one additional independent laboratory. Cut-off Level The Cut-Off Level is the response or signal from a screening test which indicates that a sample contai