156. false-negative A false-negative result for a sample indicates that the sample shows a test result of ‘negative’ for an analyte of interest although the analyte is actually present in the sample or is present at a concentration below the detection limit of the assay. In anti-drug antibody assays, the analyte is actually present in the sample but its response is below the cutoff point of the assay.
157. false-positive A false-positive result for a sample indicates that the sample shows a test result of ‘positive’ for an analyte of interest although it is not actually present in the sample. In anti- drug antibody assays, the analyte is not present in the sample but its response is above the cutoff point of the assay.
158. FDA Form 483 A form used by the US FDA to document and communicate concerns discovered during their inspections.
159. fingerprinting A reproducible pattern expressed in the data that can be used to classify individual samples into categories using a number of multivariate and/or machine learning approaches.
