- Latest available (Revised)
- Point in Time (31/12/2020)
- Original (As adopted by EU)
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)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Point in time view as at 31/12/2020.
There are currently no known outstanding effects for the Commission Implementing Decision (EU) 2020/350.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
The Annex to Decision 2002/364/EC is amended as follows:
Section 2 is amended as follows:
the following definition of ‘First line assay’ is inserted between the definition of ‘Whole system failure rate’ and the definition of ‘Confirmation assay’:
‘First-line assay
First-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.’;
the definition of ‘Confirmation assay’ is replaced by the following:
‘Confirmatory assay
Confirmatory assay means an assay used for the confirmation of a reactive result from a first-line assay.’;
Section 3 is amended as follows:
Sub-section 3.1.1 is replaced by the following:
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.’;
Sub-section 3.1.3 is replaced by the following:
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.
Performance 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.’;
Sub-section 3.1.9 is replaced by the following:
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).’;
Sub-section 3.1.11 is replaced by the following:
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.’;
Sub-section 3.4.2 is replaced by the following:
The manufacturer’s batch release testing for first line assays shall include at least 100 specimens negative for the relevant analyte.’.
Table 1 is replaced by the following:
First-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
anti-HIV 1/2, HIV 1/2 Ag/Ab | Anti-HTLV-I/II | anti-HCV, HCV Ag/Ab | HBsAg | Anti-HBc | ||
---|---|---|---|---|---|---|
Diagnostic sensitivity | Positive specimens | 400 HIV-1 100 HIV-2 including 40 non-B-subtypes, all available HIV/1 subtypes shall be represented by at least 3 samples per subtype | 300 HTLV-I 100 HTLV-II | 400 (positive samples) Including samples from different stages of infection and reflecting different antibody patterns. Genotype 1-4: > 20 samples per genotype (including non-a subtypes of genotype 4); 5: > 5 samples; 6: if available | 400 including subtype-consideration | 400 including evaluation of other HBV-markers |
Sero-conversion panels | 20 panels 10 further panels (at notified body or manufacturer) | To be defined when available | 20 panels 10 further panels (at notified body or manufacturer) | 20 panels 10 further panels (at notified body or manufacturer) | To be defined when available | |
Analytical sensitivity | Standards | 0,130 IU/ml ( WHO International Standard: Third International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226) | ||||
Specificity | Unselected donors (including first-time donors) | 5 000 | 5 000 | 5 000 | 5 000 | 5 000 |
Hospitalized patients | 200 | 200 | 200 | 200 | 200 | |
Potentially cross-reacting blood-specimens (RF+, related viruses, pregnant women, etc) | 100 | 100 | 100 | 100 | 100’ |
Table 3 is replaced by the following:
Rapid tests: anti-HIV 1/2, HIV 1/2 Ag/Ab, anti-HCV, HCV Ag/Ab, HBsAg, anti-HBc, anti-HTLV I and II
anti-HIV 1/2, HIV 1/2 Ag/Ab | anti-HCV, HCV Ag/Ab | HBsAg | anti-HBc | anti-HTLV I and II | Acceptance criteria | ||
---|---|---|---|---|---|---|---|
Diagnostic sensitivity | Positive specimens | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 |
Sero-conversion panels | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | Same criteria as in Table 1 | |
Diagnostic specificity | Negative specimens | 21 000 blood donations | 1 000 blood donations | 1 000 blood donations | 1 000 blood donations | 1 000 blood donations | ≥ 99 % (anti-HBc: ≥ 96 %) |
200 clinical specimens | 200 clinical specimens | 200 clinical specimens | 200 clinical specimens | 200 clinical specimens | |||
200 samples from pregnant women | 200 samples from pregnant women | 200 samples from pregnant women | 200 samples from pregnant women | ||||
100 potentially interfering samples | 100 potentially interfering samples | 100 potentially interfering samples | 100 potentially interfering samples | 100 potentially interfering samples’ |
Table 4 is replaced by the following:
Confirmatory and supplementary assays for anti-HIV 1/ 2, HIV 1/2 Ag/Ab, anti-HTLV I and II, anti-HCV, HCV Ag/Ab, HBsAg
a Acceptance criteria: no neutralisation for HBsAg confirmatory assay.’ | ||||||
anti-HIV 1/2, HIV 1/2 Ag/Ab confirmatory assays | anti-HTLV I and II confirmatory assays | anti-HCV, HCV Ag/Ab supplementary assays | HBsAg confirmatory assays | Acceptance criteria | ||
---|---|---|---|---|---|---|
Diagnostic sensitivity | Positive specimens | 200 HIV-1 and 100 HIV-2 Including samples from different stages of infection and reflecting different antibody patterns | 200 HTLV-I and 100 HTLV-II | 300 HCV (positive samples) Including samples from different stages of infection and reflecting different antibody patterns. Genotypes 1 – 4: > 20 samples (including non-a subtypes of genotype 4; Genotype 5: > 5 samples; Genotype 6: if available | 300 HBsAg Including samples from different stages of infection 20 ‘high pos’ samples (>26 IU/ml); 20 samples in the cut-off range | Correct identification as positive (or indeterminate), not negative |
Sero-conversion panels | 15 sero-conversion panels/low titre panels | 15 sero-conversion panels/low titre panels | 15 sero-conversion panels/low titre panels | |||
Analytical sensitivity | Standards | Third International Standard for HBsAg, subtypes ayw1/adw2, HBV genotype B4, NIBSC code: 12/226 | ||||
Diagnostic specificity | Negative specimens | 200 blood donations | 200 blood donations | 200 blood donations | 10 false positives as available from the performance evaluation of the first line assaya. | No false-positive results/a no neutralisation |
200 clinical samples including pregnant women | 200 clinical samples including pregnant women | 200 clinical samples including pregnant women | ||||
50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays | 50 potentially interfering samples, including samples with indeterminate results in other confirmatory assays | 50 potentially interfering samples, including samples with indeterminate results in other supplementary assays | 50 potentially interfering samples |
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: