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<p>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.</p>
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