Written question asked by Countess of Mar (Crossbench), in the House of Lords. It was answered by Earl Howe (Conservative) on Wednesday, 7 December 2011.

Health: Lyme Disease

Question: To ask Her Majesty’s Government whether, in view of the statement on the Medicines and Healthcare products Regulatory Agency website that their decisionswill be ““based on robust science”” and ““fact-based judgments to ensure that the benefits to patients and the public justify the risks”” of new scientific research, they have conducted a recent risk assessment of the ELISA test for Lyme disease.

Answer: We are advised by the Medicines and Healthcare products Regulatory Agency (MHRA) that manufacturers of in vitro diagnostic devices such as the enzyme-linked immunosorbent assay test should ensure they conform to the safety, quality and performance requirements of the European Commission In Vitro Diagnostic Devices Directive before they CE mark their products and place them on the European Union and United Kingdom market. This involves setting out their performance characteristics for the test and being able to demonstrate that it performs to the accuracy level claimed for it. The MHRA has a mainly post-market surveillance and enforcement role under the directive and would investigate any problems with the use of such a test that comes to its attention. Depending upon the results of any such investigation, the MHRA has a range of legal powers open to it that include removing the device from the UK market.

Secondary information