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Written question asked by Mike Hancock (Liberal Democrat) on Wednesday, 1 April 2009, in the House of Commons. It was due for an answer on Monday, 20 April 2009. It was answered by Baroness Primarolo (Labour) on Monday, 20 April 2009 on behalf of the Department of Health.


CJD: Screening

Question
To ask the Secretary of State for Health pursuant to the answer of 27 March 2009, Official Report, columns 756-7W, on CJD: screening, what the criteria are for validation of a test for variant Creuzfeldt-Jakob disease.
Answer

Any item of equipment for a variant Creutzfeldt-Jakob disease test kit must meet the essential safety requirements specified in the In Vitro Diagnostic Medical Devices Directive.The device must perform as intended by the manufacturer and meet criteria relating to sensitivity, specificity, accuracy, repeatability and reproducibility.


Secondary information

Type
Written question
Reference
491 c445-6W; 269064
Session
2008-09
Related items
CJD: Screening
Friday, 27 March 2009
Written questions
House of Commons
Subjects
Screening CJD
Link
View this Written question on www.publications.parliament.uk