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Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC), Division 2. is up to date with all changes known to be in force on or before 20 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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The probability that the device gives a positive result in the presence of the target marker.
A specimen known to be positive for the target marker and correctly classified by the device.
A specimen known to be positive for the target marker and misclassified by the device.
The probability that the device gives a negative result in the absence of the target marker.
A specimen known to be negative for the target marker and misclassified by the device.
A specimen known to be negative for the target marker and correctly classified by the device.
Analytical sensitivity may be expressed as the limit of detection, i.e. the smallest amount of the target marker that can be precisely detected.
Analytical specificity means the ability of the method to determine solely the target marker.
The term ‘NAT’ is used for tests for the detection and/or quantification of nucleic acids by either amplification of a target sequence, by amplification of a signal or by hybridisation.
‘Rapid test’ means qualitative or semi-quantitative in vitro diagnostic medical devices, used singly or in a small series, which involve non-automated procedures and have been designed to give a fast result.
The robustness of an analytical procedure means 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.
The whole system failure rate means the frequency of failures when the entire process is performed as prescribed by the manufacturer.
Confirmation assay means an assay used for the confirmation of a reactive result from a screening assay.
Virus typing assay means an assay used for typing with already known positive samples, not used for primary diagnosis of infection or for screening.
Sero-conversion HIV samples mean:
p24 antigen and/or HIV RNA positive, and
recognised by all of the antibody screening tests, and
positive or indeterminate confirmatory assays.
Early seroconversion HIV samples mean:
p24 antigen and/or HIV RNA positive, and
not recognised by all of the antibody screening tests, and
indeterminate or negative confirmatory assays.]
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