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The Annex to Decision 2002/364/EC is amended as follows:
Sub-section 3.1.1 is replaced by the following:
Section 3.2 is replaced by the following:
Sub-section 3.3.2 is replaced by the following:
The following sub-sections 3.3.2a and 3.3.2b are inserted:
Table 1 is replaced by the following:
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’ |
Table 5 is replaced by the following:
HIV 1 antigen, HIV Ag/Ab, HCV antigen, HCV Ag/Ab
a The total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30.’ | ||||
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 panelsa | 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 |