Criteria for diagnosis Fever of ≥5 days' duration associated with at least four† of these five changes Bilateral nonsuppurative conjunctivitis One or more changes of the mucous membranes of the upper respiratory tract, including throat redness, dry cracked lips, red lips, and "strawberry" tongue One or more changes of the arms and legs, including redness, swelling, skin peeling around the nails, and generalized peeling Polymorphous rash, primarily truncal Large lymph nodes in the neck (>15 mm in size) Disease cannot be explained by some other known disease process †A diagnosis of Kawasaki disease can be made if fever and only three changes are present if coronary artery disease is documented by two-dimensional echocardiography or coronary angiography. Source: Nelson's essentials of pediatrics, Review Angiography showing ectatic LAD, with largest<unk>  = 6.5 mm in diameter Since no specific laboratory test exists for Kawasaki disease, diagnosis must be based on clinical signs and symptoms, together with laboratory findings. Timely diagnosis requires careful history-taking and thorough physical examination. Establishing the diagnosis is difficult, especially early in the course of the illness, and frequently children are not diagnosed until they have seen several health-care providers. Many other serious illnesses can cause similar symptoms, and must be considered in the differential diagnosis, including scarlet fever, toxic shock syndrome, juvenile idiopathic arthritis, and childhood mercury poisoning (infantile acrodynia). Classically, five days of fever plus four of five diagnostic criteria must be met to establish the diagnosis. The criteria are: # erythema of the lips or oral cavity or cracking of the lips # rash on the trunk # swelling or erythema of the hands or feet # red eyes (conjunctival injection) # swollen lymph node in the neck of at least 15 mm Many children, especially infants, eventually diagnosed with Kawasaki disease, do not exhibit all of the above criteria. In fact, many experts now recommend treating for Kawasaki disease even if only three days of fever have passed and at least three diagnostic criteria are present, especially if other tests reveal abnormalities consistent with Kawasaki disease. In addition, the diagnosis can be made purely by the detection of coronary artery<unk> s in the proper clinical setting. Investigations A physical examination will demonstrate many of the features listed above. Blood tests * Complete blood count may reveal normocytic anemia and eventually thrombocytosis. * Erythrocyte sedimentation rate will be elevated. * C-reactive protein will be elevated. * Liver function tests may show evidence of hepatic inflammation and low serum albumin levels. Other optional tests include: * Electrocardiogram may show evidence of ventricular dysfunction or, occasionally, arrhythmia due to myocarditis. * Echocardiogram may show subtle coronary artery changes or, later, true<unk> s. * Ultrasound or computerized tomography may show hydrops (enlargement) of the gallbladder. * Urinalysis may show white blood cells and protein in the urine (pyuria and proteinuria) without evidence of bacterial growth. * Lumbar puncture may show evidence of aseptic meningitis. * Angiography was historically used to detect coronary artery<unk> s, and remains the gold standard for their detection, but is rarely used today unless coronary artery<unk> s have already been detected by echocardiography. Biopsy is rarely performed, as it is not necessary for diagnosis. Subtypes Based on clinical findings, a diagnostic distinction may be made between the 'classic' / 'typical' presentation of Kawasaki disease and 'incomplete' / 'atypical' presentation of a "suspected" form of the disease. Regarding 'incomplete' / 'atypical' presentation, American Heart Association guidelines state that Kawasaki disease "should be considered in the differential diagnosis of prolonged unexplained fever in childhood associated with any of the principal clinical features of the disease, and the diagnosis can be considered confirmed when coronary artery<unk> s are identified in such patients by echocardiography." A further distinction between 'incomplete' and 'atypical' subtypes may also be made in the presence of non-typical symptoms. Case definition For study purposes, including vaccine safety monitoring, an international case definition has been proposed to categorize 'definite' (i.e. complete/incomplete), 'probable' and 'possible' cases of Kawasaki disease. Differential diagnosis The broadness of the differential diagnosis is a challenge to timely diagnosis of Kawasaki disease. Infectious and noninfectious conditions requiring consideration include: measles and other viral infections (e.g. adenovirus, enterovirus); staphylococcal and streptococcal toxin-mediated diseases such as scarlet fever and toxic shock syndrome; drug hypersensitivity reactions (including Stevens Johnson syndrome); systemic onset juvenile idiopathic arthritis; Rocky Mountain spotted fever or other rickettsial infections; and leptospirosis. Infectious conditions that can mimic Kawasaki disease include periorbital cellulitis, peritonsillar abscess, retropharyngeal abscess, cervical lymphadenitis, parvovirus B19, mononucleosis, rheumatic fever, meningitis, staphylococcal scalded skin syndrome, toxic epidermal necrolysis, and Lyme disease. Kawasaki-like disease temporally associated with COVID-19 In 2020, reports of a Kawasaki-like disease following exposure to SARS-CoV-2, the virus responsible for COVID-19, emerged in the US and Europe. The World Health Organization is examining possible links with COVID-19. This emerging condition was named 'paediatric multisystem inflammatory syndrome' by the Royal College of Paediatrics and Child Health, and 'multisystem inflammatory syndrome in children' by the Centers for Disease Control and Prevention. Guidance for diagnosis and reporting of cases has been issued by these organizations. Classification Debate has occurred about whether Kawasaki disease should be viewed as a characteristic immune response to some infectious pathogen, as an autoimmune process, or as an autoinflammatory disease (i.e. involving innate rather than adaptive immune pathways). Overall, immunological research suggests that Kawasaki disease is associated with a response to a conventional antigen (rather than a superantigen) that involves both activation of the innate immune system and also features of an adaptive immune response. Identification of the exact nature of the immune process involved in Kawasaki disease could help guide research aimed at improving clinical management. Inflammation, or vasculitis, of the arteries and veins occurs throughout the body, usually caused by increased production of the cells of the immune system to a pathogen, or autoimmunity. Systemic vasculitides may be classified according to the type of cells involved in the proliferation, as well as the specific type of tissue damage occurring within the vein or arterial walls. Under this classification scheme for systemic vasculitis, Kawasaki disease is considered to be a necrotizing vasculitis (also called necrotizing angiitis), which may be identified histologically by the occurrence of necrosis (tissue death), fibrosis, and proliferation of cells associated with inflammation in the inner layer of the vascular wall. Other diseases involving necrotizing vasculitis include polyarteritis nodosa, granulomatosis with polyangiitis, Henoch–Schönlein purpura, and eosinophilic granulomatosis with polyangiitis. Kawasaki disease may be further classified as a medium-sized vessel vasculitis, affecting medium- and small-sized blood vessels, such as the smaller cutaneous vasculature (veins and arteries in the skin) that range from 50 to 100 µm in diameter. Kawasaki disease is also considered to be a primary childhood vasculitis, a disorder associated with vasculitis that mainly affects children under the age of 18. A recent, consensus-based evaluation of vasculitides occurring primarily in children resulted in a classification scheme for these disorders, to distinguish them and suggest a more concrete set of diagnostic criteria for each. Within this classification of childhood vasculitides, Kawasaki disease is, again, a predominantly medium-sized vessel vasculitis. It can also be classed as an autoimmune form of vasculitis. It is not associated with anti-neutrophil cytoplasmic antibodies, unlike other vasculitic disorders associated with them (such as granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis). This form of categorization is relevant for appropriate treatment.
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