Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what evidence existed to show that the Health Protection Agency’s Lyme Borreliosis Unit (LBU) conformed with European Union and United Kingdom legislation for the use of the Trinity Biotech kit for <i>in vitro</i> testing when used with cerebrospinal fluid; and what testing was carried out by the LBU to verify that the use of that test kit was suitable, and sufficiently sensitive, for the detection of European and United Kingdom species of Borrelia infections in cerebrospinal fluid.

The former Health Protection Agency's Lyme Borreliosis Unit adhered to legislation related to diagnostic testing. The Trinity Biotech Lyme Western Blot technique was widely used in Europe at that time for serum and samples. Controls were run with each batch of the test to verify the tests accuracy and sensitivity. Quality assurance samples were run to ensure independent validation of the results.