NURSING EXAM QUESTIONS
PATHOLOGY AND GENETICS
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Question
[CLICK ON ANY CHOICE TO KNOW THE RIGHT ANSWER]
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a new third party reagent is being introduced
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a new analytical measuring system is being introduced
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the manufacturer changes the reagent formulation
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IQC performance showing within acceptable performance
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Detailed explanation-1: -Analytical method verification is usually required when a compendial method or a previously validated method is being performed with new or different products, equipment, laboratories to generate appropriate results for the first time.
Detailed explanation-2: -Method verification is the main step in the process of enhancing the quality of laboratory results and a cornerstone in accreditation. Despite the presence of several updated guidelines used to determine the performance characteristics of new methods in clinical chemistry laboratories.
Detailed explanation-3: -These methods include quantitative assays and limit tests, titrimetric and bacterial endotoxin tests. Analytical methods for determination of performance characteristics, e.g., sterility testing, dissolution and drug release for pharmaceutical products. Data Elements Required for Assay Validation.