Transcription of PRINCIPLES AND METHODS OF VALIDATION OF …
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PRINCIPLES AND METHODS OF VALIDATION OF …
2019 OIE - Manual of diagnostic tests for Aquatic Animals - 19/08/20191 CHAPTER AND METHODS OFVALIDATION OF DIAGNOSTIC ASSAYSFOR INFECTIOUS DISEASESINTRODUCTION1 VALIDATION is a process that determines the fitness of an assay2, which has been properly developed,optimised and standardised, for an intended purpose. All diagnostic assays ( laboratory and field assays)should be validated for the species in which they will be used. VALIDATION includes estimates of theanalytical and diagnostic performance characteristics of a test. In the context of this chapter, an assay thathas completed the first three stages of the VALIDATION pathway (see Figure 1 below), including performancecharacterisation, can be designated as validated for the original intended purpose(s) . To maintain avalidated assay status, however, it is necessary to carefully monitor the assay's performance underconditions of routine use, often by tracking the behaviour of assay controls over time.
All diagnostic assays (laboratory and field assays) should be validated for the species in which they will be used. Validation includes estimates of the analytical and diagnostic performance characteristics of a test. In the context of this chapter, an assay that ... validation of diagnostic tests for infectious diseases ap plicable to wildlife ...
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