# 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 3.3.2

Extent: E+W+S+N.I.

The analytical sensitivity or detection limit for NAT assays shall be expressed by the 95 % positive cut-off value. This is the analyte concentration where 95 % of test runs give positive results following serial dilutions of an international reference material, where available, such as a World Health Organisation (WHO) International Standard or reference material calibrated against a WHO International Standard.

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Source: https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.3/division/3.3.2 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.3/division-3.3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.