{
  "url": "https://openlegislation.uk/eu-decision-2019-1244/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2019-1244/annex.json",
  "legislation": "eudn/2019/1244",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2019-1244",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The Annex to Decision 2002/364/EC is amended as follows:\n(1) Sub-section 3.1.1 is replaced by the following:\n‘3.1.1\nDevices which detect virus infections shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5 according to virus type and entities detected (antigen and/or antibody). See also principle 3.1.11 for screening assays.’\n(2) Section 3.2 is replaced by the following:\n‘3.2.\nAdditional requirements for HIV and HCV antigen and antibody combined tests.\n3.2.1.\nHIV antigen and antibody combined tests intended for the detection of HIV-1 p24 antigen and HIV-1/2 antibody shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5.\n3.2.2.\nHepatitis C virus (HCV) antigen and antibody combined tests intended for the detection of HCV antigen and HCV antibody shall meet the requirements for sensitivity and specificity set out in Table 1 and Table 5. HCV seroconversion panels for the evaluation of HCV antigen and antibody combined tests shall start with one or more negative bleeds and comprise panel members from early HCV infection (HCV core antigen and/or HCV RNA positive but anti-HCV negative). HCV antigen and antibody combined tests shall demonstrate enhanced sensitivity in early HCV infection when compared to HCV antibody only tests.’\n(3) Sub-section 3.3.2 is replaced by the following:\n‘3.3.2.\nThe 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.’\n(4) The following sub-sections 3.3.2a and 3.3.2b are inserted:\n‘3.3.2a.\nQualitative HIV NAT assays intended to be used to detect the presence of HIV in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration shall be designed to detect both HIV-1 and HIV-2.\n3.3.2b.\nQualitative HIV NAT assays, other than virus typing assays, shall be designed to compensate for the potential failure of a HIV-1 NAT target region, e.g. by using two independent target regions.’\n(5) Table 1 is replaced by the following:\n‘\nTable 1\nScreening assays: anti-HIV 1/2, HIV 1/2 Ag/Ab, anti-HTLV I/II, anti-HCV, HCV Ag/Ab, HBsAg, anti-HBc\nanti-HIV 1/2, HIV 1/2 Ag/Ab\nAnti-HTLV-I/II\nanti-HCV, HCV Ag/Ab\nHBsAg\nAnti-HBc\nDiagnostic sensitivity\nPositive specimens\n400 HIV-1\n100 HIV-2\nincluding 40 non-B-subtypes, all available HIV/1 subtypes shall be represented by at least 3 samples per subtype\n300 HTLV-I\n100 HTLV-II\n400 (positive samples)\nIncluding samples from different stages of infection and reflecting different antibody patterns.\nGenotype 1-4: > 20 samples per genotype (including non-a subtypes of genotype 4);\n5: > 5 samples;\n6: if available\n400\nincluding subtype-consideration\n400\nincluding evaluation of other HBV-markers\nSero-conversion panels\n20 panels\n10 further panels (at Notified Body or manufacturer)\nTo be defined when available\n20 panels\n10 further panels (at Notified Body or manufacturer)\n20 panels\n10 further panels (at Notified Body or manufacturer)\nTo be defined when available\nAnalytical sensitivity\nStandards\n0,130 IU/ml (WHO International Standard: Third International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226)\nSpecificity\nUnselected donors (including first-time donors)\n5 000\n5 000\n5 000\n5 000\n5 000\nHospitalized patients\n200\n200\n200\n200\n200\nPotentially cross-reacting blood-specimens (RF+, related viruses, pregnant women, etc.)\n100\n100\n100\n100\n100\n’\n(6) Table 5 is replaced by the following:\n‘\nTable 5\nHIV 1 antigen, HIV Ag/Ab, HCV antigen, HCV Ag/Ab\nThe total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30.\nHIV-1 antigen and HIV Ag/Ab assays\nHCV antigen and HCV Ag/Ab assays\nAcceptance criteria\nDiagnostic sensitivity\nPositive specimens\n50 HIV-1 antigen positive\n50 cell culture supernatants including different HIV-1 subtypes and HIV-2\n25 HCV core antigen and/or HCV RNA positive but anti-HCV negative samples, comprising HCV genotypes 1-6 (if a genotype is not available, a justification shall be made)\nSee general principle in § 3.1.8\nSero-conversion panels\n20 sero-conversion panels/low titre panels\n20 sero-conversion panels/low titre panels\nAnalytical sensitivity\nStandards\nHIV-1 p24 Antigen, First International Reference Reagent, NIBSC code: 90/636\nHCV core antigen detection limit shall be investigated using dilutions of the WHO International HCV core antigen Standard: (HCV core Ag product code: PEI 129096/12)\nFor HIV-1 p24 antigen: ≤ 2 IU/ml\nDiagnostic specificity\n200 blood donations\n200 clinical samples\n50 potentially interfering samples\n200 blood donations, 200 clinical samples, 50 potentially interfering samples\n≥ 99,5 % after neutralisation or, if no neutralisation test available, after resolution of the sample status according to general principles in § 3.1.5\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "The total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2019/1244/annex",
    "retrieved_at": "2026-11-01T15:12:37.967137+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."
}