confirmatory assaymeans a device used for the confirmation of a reactive result from a first line assay;
cross-reactivitymeans the ability of non-target analytes or markers to cause false positive results in an assay because of similarity, e.g. the ability of non-specific antibodies binding to a test antigen of an antibody assay, or the ability of non-target nucleic acids to be reactive in a NAT assay;
false negativemeans a specimen known to be positive for the target marker and misclassified by the device;
false positivemeans a specimen known to be negative for the target marker and misclassified by the device;
first-line assaymeans a device used to detect a marker or analyte, and the use of which may be followed by the use of a confirmatory assay;
interferencemeans the ability of unrelated substances to affect the results in an assay;
nucleic acid amplification techniques(‘NAT’) means methods of detection and/or quantification of nucleic acids by either amplification of a target sequence, by amplification of a signal or by hybridisation;
rapid testmeans a qualitative or semi-quantitative in vitro diagnostic medical device, used singly or in a small series, which involves non-automated procedures (except the reading of results) and has been designed to give a fast result;
robustnessmeans the capacity of an analytical procedure to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage;
supplemental assaymeans a device that is used to provide further information for the interpretation of the test result of another assay;
the limit of detection(‘LOD’) means the smallest amount of the target marker that can be detected;
true positivemeans a specimen known to be positive for the target marker and correctly classified by the device;
virus typing devicemeans a device used for typing with already known positive samples, not used for primary diagnosis of infection or for screening;
whole system failure ratemeans the frequency of failures when the entire process is performed as prescribed by the manufacturer;