Lyme disease

Quality statement

People with suspected Lyme disease without erythema migrans who have a negative enzyme-linked immunosorbent assay (ELISA) test carried out within 4 weeks of their symptoms starting have the test repeated 4 to 6 weeks later if Lyme disease is still suspected.

Rationale

The timing of the initial ELISA test is important for diagnosing Lyme disease in people without erythema migrans. If the test is performed too early (within 4 weeks of symptom onset) the person may not have developed antibodies to the bacteria that causes Lyme disease, resulting in a 'false negative' result. People in whom Lyme disease is still suspected and who had a negative initial ELISA test result may have had the test too early. Repeating the test 4 to 6 weeks after the first test supports an accurate diagnosis. The diagnostic process is summarised in NICE's visual summary of the recommendations for testing for Lyme disease.

Quality measures

What the quality statement means for different audiences

Service providers (such as primary care and local microbiology laboratories) have local arrangements in place to ensure that people without erythema migrans in whom Lyme disease is still suspected after an initial negative ELISA test result for Lyme disease within 4 weeks of onset of symptoms have the test repeated 4 to 6 weeks later. If there is no local diagnostic service, the sample is tested at the Rare and Imported Pathogens Laboratory (RIPL).

Healthcare professionals (such as GPs and clinicians in secondary care) repeat an ELISA test 4 to 6 weeks after the first test for people without erythema migrans in whom Lyme disease is still suspected after an initial negative ELISA test result for Lyme disease within 4 weeks of onset of symptoms. They are aware of local arrangements to support ordering the repeat test.

Commissioners (such as clinical commissioning groups and NHS England) commission local microbiology laboratory services to perform a repeat ELISA test 4 to 6 weeks after the first test for people without erythema migrans if Lyme disease is still suspected after an initial negative ELISA test result for Lyme disease within 4 weeks of onset of symptoms. If there is no local diagnostic service, the sample is tested at the RIPL.

People without erythema migrans who had a negative blood test for Lyme disease in the 4 weeks after their symptoms began, but continue to have symptoms, have another blood test 4 to 6 weeks after their first test. This will help to make sure they are correctly diagnosed.

Source guidance

Lyme disease. NICE guideline NG95 (2018), recommendation 1.2.17

Definition of terms used in this quality statement