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 in carrying out testing of cerebrospinal fluid of patients suspected of having Lyme disease using the Trinity Biotech kit.

The former Health Protection Agency's Lyme Borreliosis Unit (HPA LBU) informed requesting clinicians but not patients of the results on cerebrospinal fluid (CSF) and also provided a clinical interpretive service to the requesting clinician. Referring laboratories and clinicians managing patients with Lyme disease were aware of the limitations of diagnostic tests for serum and CSF through publications and educational meetings. 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. It is also important to note that the former HPA’s LBU performed diagnostic tests on samples referred by other laboratories