Lyme Disease

House of Lords written question – answered on 29th July 2014.

Alert me about debates like this

Photo of The Countess of Mar The Countess of Mar Deputy Chairman of Committees, Deputy Speaker (Lords)

To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 25 June 2012 (WA 21-2), whether they consider that the use of the CE-marked Trinity Biotech EU Lyme western blot test, when used with cerebrospinal fluid, would constitute “use of an in-house test” as defined by the Medical and Healthcare Products Regulatory Agency guidance.

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

Use of a sample type not indicated by the manufacturer would be considered to be off label use of the device. This off label use is not regulated by the Medicines and Healthcare products Regulatory Agency and would be the responsibility of the laboratory.

Does this answer the above question?

Yes1 person thinks so

No0 people think not

Would you like to ask a question like this yourself? Use our Freedom of Information site.