Criteria

Serologic Diagnostic Criteria recommended by Second National Conference on Serologic Diagnosis of Lyme Disease (1994)​[32]

A 2-tier approach is recommended:

  • Use a sensitive enzyme immunoassay (EIA) or immunofluorescence assay (IFA) as a first step, and if positive or equivocal, confirm with standardized Western blot assay. In 2019, some EIAs were approved by the Food and Drug Administration for serologic diagnosis of Lyme disease and can be used in place of Western blot assays for the second step.[34]

  • Specimens negative by a sensitive EIA or IFA need not be tested further.

  • For early Lyme disease (first 4 weeks), Western blot should be done for both IgM and IgG antibodies.

  • In a patient with suspected early Lyme disease who has a negative EIA, a repeat serologic test should be done during the convalescent phase (paired sera samples) >2 weeks later.

People with disseminated or late Lyme disease show a strong IgG response to Borrelia burgdorferi antigens.

Diagnostic criteria for CNS Lyme disease Lyme neuroborreliosis recommended by European Federation of Neurological Societies[37]

Criteria for diagnosis of central nervous system (CNS) Lyme disease (excluding late CNS Lyme disease with polyneuropathy):

  • Neurologic symptoms suggestive of CNS Lyme disease and exclusion of other causes

  • Cerebrospinal fluid (CSF) pleocytosis

  • Presence of B burgdorferi-specific antibodies in CSF (produced intrathecally).

Definite CNS Lyme disease requires all 3 criteria. Possible CNS Lyme disease requires 2 of the 3 criteria; if a third criterion is missing, a repeat test done 6 weeks later needs to be positive.

The following 3 criteria need to be met for definite diagnosis of late CNS Lyme disease with polyneuropathy:

  • Peripheral neuropathy

  • Clinical diagnosis of acrodermatitis chronica atrophicans

  • Presence of B burgdorferi-specific antibodies in serum.

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