Question to the Department of Health and Social Care:

To ask Her Majesty’s Government whether the Health Protection Agency's Lyme Borreliosis Unit informed clinicians and patients of test results on cerebrospinal fluid in accordance with Medicines and Healthcare Products Regulatory Agency guidance on devices used off-label.

The former Health Protection Agency's Lyme Borreliosis Unit informed requesting clinicians but not patients of the results on cerebrospinal fluid (CSF) and also provided a clinical interpretive service to the requesting clinician. There was no approved ‘on-label’ test for CSF at that time, which is why the use of this test was carefully controlled and its quality assured in each test run. It is the role of the requesting clinician to be guided by the interpretation of the laboratory result and to use these results in the light of the clinical presentation to make a diagnosis and a management plan for individual patients. In addition to the controls for the test, the CSF sample was run with the patient’s serum. If the patient had Lyme disease, serology would have demonstrated this and the patient treated appropriately for their clinical presentation whether the CSF was positive or negative.