House of Lords written question – answered at on 12 December 2011.
To ask Her Majesty's Government why the Lyme Unit of the Health Protection Agency does not advise patients and their doctors of the advice of the manufacturers of test kits that indicates that a negative result from the Lyme ELISA test, particularly in the early and late stages of infection, does not necessarily exclude Lyme disease and that a patient's clinical signs and symptoms as well as a case history must be included when a diagnosis is being considered.
The Health Protection Agency's (HPA) Lyme Borreliosis Reference Laboratory does advise clinicians that antibody tests may be negative for several weeks after infection has occurred due to the low level of antigenic stimulation in the early stage of infection. It provides information on its test result sheets about the appropriate application and limitations of tests for antibodies to borrelia burgdorferi and indicates that the predictive value of any test result is greatly affected by the pre-test probability of infection. It advises clinicians that the clinical significance of results should be assessed in light of the patient's clinical findings. The advice on the HPA's test results sheet indicates that antibody tests are rarely negative in late Lyme borreliosis. It advises clinicians that alternative causes should be carefully excluded before a diagnosis of seronegative late Lyme borreliosis is accepted. It also advises that antibody positivity may be related to past rather than current infection.
The HPA reports its test results to the requesting clinician and it would be for the clinician to inform patients about the significance of their test result.
Yes2 people think so
No28 people think not
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