True positive and true negative are determined using a gold standard, such as an established reference assay or a definitive clinical diagnosis. TrueFalse When FDA-approved or FDA-cleared methods are incorporated, the test performance is verified by using the purchased reagent sets to test validation specimens. This verification establishes that the results of the commercial test performed in the individual laboratory are as predicted by the developer. TrueFalse The negative predictive value is the degree that a particular test result corresponds with the presence of a clinical state, such as disease symptoms or response to therapeutic agent. TrueFalse The positive predictive value is the clinical specificity of the test, that is, the absence of that test result in the absence of the disease state or response. TrueFalse Answ

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