Validating laboratory tests speed dating events in halifax

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Paulo Pereira introduces some of the basic concepts of method validation that apply when a qualitative method is being evaluated.The validation of qualitative tests differs from the quantitative tests principally since there are no numerical results but binary results, e.g., positive/negative result.Below are the most common reasons: This site uses cookies to improve performance by remembering that you are logged in when you go from page to page.To provide access without cookies would require the site to create a new session for every page you visit, which slows the system down to an unacceptable level.ISO defines verification as the “confirmation, through the provision of objective evidence, which specified requirements had been fulfilled” (3.8.12 of [2]).

However, they could be related to nominal quantities or ordinal quantities [1].Ordinal quantities are linked to the “pure” qualitative test result, where only a binary condition is known.Nominal quantities are related to binary results arising from the comparison of a numerical quantity results on an ordinal scale considering a certain decision point or “cutoff.” Sometimes in medical laboratories terminology, nominal tests are referred as qualitative - e.g., agglutination/positive/no-agglutination/negative in a slide, number of crosses of an observed certain reagent - and ordinal tests as semi-quantitative - e.g., positive result given that 4.12 is equal or higher than the “cutoff”=1.00.This classification is referred as diagnostic sensitivity Se[%] when “the percentage (number fraction multiplied by 100) of subjects with the target condition (as determined by the diagnostic accuracy criteria) whose test values are positive”, and diagnostic specificity Sp[%] when “the percentage (number fraction multiplied by 100) of subjects without the target condition (as determined by the diagnostic accuracy criteria) whose test values are negative” (5.3 of [3]).The comparison of methods can be determined primarily when the comparator is the diagnostic accuracy criteria, or it can be determined secondarily when the comparator is other than the diagnostic accuracy criteria.

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