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. 2023 Dec 9;13(12):e070903. doi: 10.1136/bmjopen-2022-070903

Table 3.

LD case definitions

Presentation Sign/symptom (detailed definition) Diagnostic(s)*
Erythema migrans†
  • Characteristic red or bluish-red patch, with or without central clearing‡

  (Lesion should be photographed.)§
  • Positive IgG/IgM on serum antibody testing.

  • Positive PCR of Bbsl result from skin biopsy.

  • Positive culture of Bbsl from skin biopsy.

    
Borrelial lymphocytoma†
  • Painless bluish red nodule or plaque, usually on ear lobe, ear helix, nipple or scrotum

  (Nodule/plaque should be photographed.)§
  • Positive IgG/IgM on serum antibody testing.

  • Positive PCR of Bbsl result from biopsy.

  • Positive culture of BbsI from biopsy.

Acrodermatitis chronica atrophicans†
  • Long-standing red or bluish-red lesions, usually on the extensor surfaces of extremities. Initially doughy swelling. Possible skin induration and fibroid nodules over bony prominences.

  (Nodule/plaque/lesion should be photographed.)§
  • Positive IgG/IgM on serum antibody testing.

  • Positive PCR of Bbsl result from biopsy.

  • Positive culture of BbsI from biopsy.

Lyme neuroborreliosis†
  • Meningoradiculitis (Bannwarth syndrome), facial palsy, meningitis, encephalomyelitis or cerebral vasculitis

  (Clinical manifestation (eg, facial palsy) should be photographed if applicable.)§
  • Intrathecal IgM and/or IgG antibodies.

  • Positive intrathecal anti-Borrelia antibody index (CSF vs serum) reflecting intrathecal antibody production.

  • Positive PCR of Bbsl result from cerebrospinal fluid.

  • Positive culture of BbsI from cerebrospinal fluid.

Lyme carditis†
  • Acute onset of high degree atrioventricular conduction disturbances, rhythm disturbances, myocarditis or pancarditis

  • Positive IgG/IgM on serum antibody testing.

  
Lyme arthritis†
  • Marked swelling in one or few large joints, most often the knee.

  (Clinical manifestation (eg, swollen joint) should be photographed.)§
  • Positive IgG/IgM on serum antibody testing.

  • Positive PCR of Bbsl result from synovial fluid or tissue.

  • Positive culture of BbsI from synovial fluid or tissue.

LD ocular manifestations†
  • Conjunctivitis, uveitis, papillitis, episcleritis or keratitis

  • Positive IgG/IgM on serum antibody testing.

  • Positive PCR of Bbsl result from ocular fluid.

  • Positive culture of BbsI from ocular fluid.

*Laboratory confirmation will primarily come from dedicated specimens collected specifically for the study (ie, serum and skin biopsy specimens). At least one positive diagnostic test result is required for laboratory confirmation.

†These clinical manifestations categories are disseminated Lyme manifestations. EM will only be considered disseminated if there are multiple EM lesions.

‡EM cases can be diagnosed on the basis of clinical symptoms alone.

§Photos will be taken in a manner as to not identify the participant and may be declined at the time of the procedure by the participant.

Bbsl, Borrelia burgdorferi sensu lato; CSF, cerebrospinal fluid; EM, erythema migrans; IgG, immunoglobulin G; IgM, immunoglobulin M; LD, Lyme disease.