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Table 2 Suggested criteria for ASIA diagnosis

From: Autoimmunity in connection with a metal implant: a case of autoimmune/autoinflammatory syndrome induced by adjuvants

Major criteria Minor criteria
Exposure to an external stimulus (infection, vaccine, silicone, adjuvant) prior to clinical manifestations. Appearance of autoantibodies or antibodies directed at the suspected adjuvant.
Appearance of one of the clinical manifestations listed below: myalgia, myositis, or muscular weakness. Arthralgia and/or arthritis. Chronic fatigue, non-restful sleeps, or sleep disturbances. Neurological manifestations (especially those associated with demyelination), cognitive impairment, memory loss. Pyrexia. Dry mouth. Other clinical manifestations (i.e., irritable bowel syndrome).
Removal of inciting agent induces improvement. Specific HLA (i.e., HLA DRB1, HLA DQB1)
Typical biopsy of involved organs. Evolvement of an autoimmune disease (i.e., multiple sclerosis, systemic sclerosis).
There must be the presence of at least two major or one major and two minor criteria.
  1. From Shoenfeld and Agmon-Levin [1]