{
  "url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.3/division-3.3.2",
  "json_url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.3/division-3.3.2.json",
  "legislation": "eudn/2002/364",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-364",
  "path": "annex/division/3/division/3.3/division/3.3.2",
  "kind": "division",
  "number": "3.3.2",
  "heading": null,
  "text": "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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "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)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (notified under document C(2019) 4632) (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.3/division/3.3.2",
    "retrieved_at": "2026-11-01T15:18:33.780237+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}