{
  "url": "https://openlegislation.uk/eu-decision-2020-350/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2020-350/annex.json",
  "legislation": "eudn/2020/350",
  "legislation_title": "Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (notified under document C(2020) 1086) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-350",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The Annex to Decision 2002/364/EC is amended as follows:\n1.. Section 2 is amended as follows:\n(a) the following definition of ‘First line assay’ is inserted between the definition of ‘Whole system failure rate’ and the definition of ‘Confirmation assay’:\n‘ First-line assay\nFirst-line assay means an assay used to detect a marker or analyte, and which may be followed by a confirmatory assay. Devices intended solely to be used to monitor a previously determined marker or analyte are not considered first-line assays.’;\n(b) the definition of ‘Confirmation assay’ is replaced by the following:\n‘ Confirmatory assay\nConfirmatory assay means an assay used for the confirmation of a reactive result from a first-line assay.’;\n2.. Section 3 is amended as follows:\n(a) Sub-section 3.1.1 is replaced by the following:\n3.1.1. ‘Devices which detect virus infections shall meet the requirements for sensitivity and specificity set out in Table 1, Table 3, Table 4 and Table 5, which apply to them taking account of the intended purpose of the devices concerned, virus type and entities to be detected (antigen and/or antibody). See also principle 3.1.11 for first-line assays.’;\n(b) Sub-section 3.1.3 is replaced by the following:\n3.1.3. ‘Devices for self-testing shall meet the same CTS requirements for sensitivity and specificity as respective devices for professional use. Relevant parts of the performance evaluation shall be carried out (or repeated) by appropriate lay users to validate the operation of the device and the instructions for use. The lay users selected for the performance evaluation shall be representative of the intended users groups.\nPerformance evaluation of a device for self-testing shall include, for each body fluid claimed for use with the device, e.g. whole blood, urine, saliva, etc., at least 200 lay users that are known positive for the infection and at least 400 lay users that do not know their status, of which at least 200 are at high risk of acquiring the infection. The sensitivity and specificity of the device for self-testing in the hands of lay users shall be defined against the confirmed patient infectious status.’;\n(c) Sub-section 3.1.9 is replaced by the following:\n3.1.9. ‘Performance evaluation of first line assays shall include 25 positive (if available in the case of rare infections) ‘same day’ fresh serum samples (≤ 1 day after sampling).’;\n(d) Sub-section 3.1.11 is replaced by the following:\n3.1.11. ‘For performance evaluations for first line assays (Table 1 and Table 3) blood donor populations shall be investigated from at least two blood donation centers and consist of consecutive blood donations, which have not been selected to exclude first time donors.’;\n(e) Sub-section 3.4.2 is replaced by the following:\n3.4.2. ‘The manufacturer’s batch release testing for first line assays shall include at least 100 specimens negative for the relevant analyte.’.\n3.. Table 1 is replaced by the following:\n‘\nTable 1\nFirst-line assays, excluding rapid tests: 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’\n4.. Table 3 is replaced by the following:\n‘\nTable 3\nRapid tests: anti-HIV 1/2, HIV 1/2 Ag/Ab, anti-HCV, HCV Ag/Ab, HBsAg, anti-HBc, anti-HTLV I and II\nanti-HIV 1/2, HIV 1/2 Ag/Ab\nanti-HCV, HCV Ag/Ab\nHBsAg\nanti-HBc\nanti-HTLV I and II\nAcceptance criteria\nDiagnostic sensitivity\nPositive specimens\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSero-conversion panels\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nSame criteria as in Table 1\nDiagnostic specificity\nNegative specimens\n21 000 blood donations\n1 000 blood donations\n1 000 blood donations\n1 000 blood donations\n1 000 blood donations\n≥ 99 %\n(anti-HBc: ≥ 96 %)\n200 clinical specimens\n200 clinical specimens\n200 clinical specimens\n200 clinical specimens\n200 clinical specimens\n200 samples from pregnant women\n200 samples from pregnant women\n200 samples from pregnant women\n200 samples from pregnant women\n100 potentially interfering samples\n100 potentially interfering samples\n100 potentially interfering samples\n100 potentially interfering samples\n100 potentially interfering samples\n’\n5.. Table 4 is replaced by the following:\n‘\nTable 4\nConfirmatory and supplementary assays for anti-HIV 1/ 2, HIV 1/2 Ag/Ab, anti-HTLV I and II, anti-HCV, HCV Ag/Ab, HBsAg\nAcceptance criteria: no neutralisation for HBsAg confirmatory assay.\nanti-HIV 1/2, HIV 1/2 Ag/Ab confirmatory assays\nanti-HTLV I and II confirmatory assays\nanti-HCV, HCV Ag/Ab supplementary assays\nHBsAg confirmatory assays\nAcceptance criteria\nDiagnostic sensitivity\nPositive specimens\n200 HIV-1 and 100 HIV-2\nIncluding samples from different stages of infection and reflecting different antibody patterns\n200 HTLV-I and 100 HTLV-II\n300 HCV (positive samples)\nIncluding samples from different stages of infection and reflecting different antibody patterns.\nGenotypes 1 – 4: > 20 samples (including non-a subtypes of genotype 4;\nGenotype 5: > 5 samples;\nGenotype 6: if available\n300 HBsAg\nIncluding samples from different stages of infection\n20 ‘high pos’ samples (>26 IU/ml); 20 samples in the cut-off range\nCorrect identification as positive (or indeterminate), not negative\nSero-conversion panels\n15 sero-conversion panels/low titre panels\n15 sero-conversion panels/low titre panels\n15 sero-conversion panels/low titre panels\nAnalytical sensitivity\nStandards\nThird International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226\nDiagnostic specificity\nNegative specimens\n200 blood donations\n200 blood donations\n200 blood donations\n10 false positives as available from the performance evaluation of the first line assay.\nNo false-positive results/ no neutralisation\n200 clinical samples including pregnant women\n200 clinical samples including pregnant women\n200 clinical samples including pregnant women\n50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays\n50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays\n50 potentially interfering samples, including samples with indeterminate results in other supplementary assays\n50 potentially interfering samples\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Acceptance criteria: no neutralisation for HBsAg confirmatory assay."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2020/350/annex",
    "retrieved_at": "2026-11-01T15:12:22.094312+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."
}