[F1 ANNEX U.K. COMMON TECHNICAL SPECIFICATIONS (CTS) FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES

Textual Amendments

F1 Substituted by Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC).

2. DEFINITIONS AND TERMS U.K.

(Diagnostic) sensitivity U.K.

The probability that the device gives a positive result in the presence of the target marker.

True positive U.K.

A specimen known to be positive for the target marker and correctly classified by the device.

False negative U.K.

A specimen known to be positive for the target marker and misclassified by the device.

(Diagnostic) specificity U.K.

The probability that the device gives a negative result in the absence of the target marker.

False positive U.K.

A specimen known to be negative for the target marker and misclassified by the device.

True negative U.K.

A specimen known to be negative for the target marker and correctly classified by the device.

Analytical sensitivity U.K.

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 U.K.

Analytical specificity means the ability of the method to determine solely the target marker.

Nucleic acid amplification techniques (NAT) U.K.

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 U.K.

‘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.

Robustness U.K.

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.

Whole system failure rate U.K.

The whole system failure rate means the frequency of failures when the entire process is performed as prescribed by the manufacturer.

Confirmation assay U.K.

Confirmation assay means an assay used for the confirmation of a reactive result from a screening assay.

Virus typing assay U.K.

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 U.K.

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 sero-conversion HIV samples U.K.

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.]