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.)

Article 1

The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall apply from 2 July 2020.
Until that date, Member States shall apply the presumption of compliance referred to in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following specifications:
(a)
the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EU  ( 4 ) ;
(b)
the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.

Article 3

This Decision is addressed to the Member States.

ANNEX

ANNEX
The Annex to Decision 2002/364/EC is amended as follows:
(1)
Sub-section 3.1.1 is replaced by the following:
‘3.1.1
Devices 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.’
(2)
Section 3.2 is replaced by the following:
‘3.2.    Additional requirements for HIV and HCV antigen and antibody combined tests.
3.2.1.
HIV 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.
3.2.2.
Hepatitis 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.’
(3)
Sub-section 3.3.2 is replaced by the following:
‘3.3.2.
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.’
(4)
The following sub-sections 3.3.2a and 3.3.2b are inserted:
‘3.3.2a.
Qualitative 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.
3.3.2b.
Qualitative 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.’
(5)
Table 1 is replaced by the following:
‘ Table 1
Screening assays: 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’
(6)
Table 5 is replaced by the following:
‘ Table 5
HIV 1 antigen, HIV Ag/Ab, HCV antigen, HCV Ag/Ab
HIV-1 antigen and HIV Ag/Ab assays
HCV antigen and HCV Ag/Ab assays
Acceptance criteria
Diagnostic sensitivity
Positive specimens
50 HIV-1 antigen positive
50 cell culture supernatants including different HIV-1 subtypes and HIV-2
25 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)
See general principle in § 3.1.8
Sero-conversion panels  ( 1 )
20 sero-conversion panels/low titre panels
20 sero-conversion panels/low titre panels
Analytical sensitivity
Standards
HIV-1 p24 Antigen, First International Reference Reagent, NIBSC code: 90/636
HCV 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)
For HIV-1 p24 antigen: ≤ 2 IU/ml
Diagnostic specificity
200 blood donations
200 clinical samples
50 potentially interfering samples
200 blood donations, 200 clinical samples, 50 potentially interfering samples
≥ 99,5 % after neutralisation or, if no neutralisation test available, after resolution of the sample status according to general principles in § 3.1.5
( 1 )   The total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30.’

Schedules & Appendices

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