Division 2 The following table is added at the end of the Annex to Decision 2002/364/EC:

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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 %

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