# Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) (Text with EEA relevance) (2011/869/EU), Division 2: The following table is added at the end of the Annex to Decision 2002/364/EC:

Extent: E+W+S+N.I.

‘
Table 11
Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening
Material
Number of specimens
Acceptance Criteria
Analytical sensitivity
vCJD brain spikes in human plasma (WHO reference number NHBY0/0003)
24 replicates of each of three dilutions of the material WHO number NHBY0/0003
(1×104, 1×105, 1×106)
23 of the 24 replicates detected at
1×104
vCJD spleen spikes in human plasma (10 % spleen homogenate — NIBSC reference number NHSY0/0009)
24 replicates of each of three dilutions of the material NIBSC number NHSY0/0009
(1×10, 1×102, 1×103)
23 of the 24 replicates detected at
1×10
Diagnostic sensitivity
A)
Specimen from appropriate animal models
As many specimen as reasonably possible and available, and at least 10 specimens
90 %
B)
Specimen from humans with known clinical vCJD
As many specimen as reasonably possible and available, and at least 10 specimens
90 %
Only in case where 10 specimens are not available:
the number of specimens tested shall be comprised between 6 and 9
all available specimens shall be tested
no more than one false negative result
Analytical specificity
Potentially cross-reacting blood-specimens
100
Diagnostic specificity
Normal human plasma samples from area of low BSE exposure
5 000
At least 99,5 %
’

---
Source: https://www.legislation.gov.uk/eudn/2011/869/annex/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2011-869/annex/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.