FDA has provided further flexibility by allowing commercial launch of a diagnostic assay as early as 15 business days prior to emergency use authorization submission as of Ma( FDA: Coronavirus (COVID-19) Update - FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics ).Increasing demand continues to outpace assay reagents and supplies.Emergency use authorization adoption has led to rapid expansion of testing capacity in the U.S.Congress, allows for expedited Food and Drug Administration (FDA) review (within 24 hours in many cases) based on less stringent validation standards than in nonurgent situations ( FDA: Coronavirus (COVID-19) Update - FDA Expedites Review of Diagnostic Tests to Combat COVID-19 ) Emergency use authorization (EUA), put into place by U.S.MIS-C may begin weeks after infection with SARS-CoV-2.Elevated interleukin 6 (median 135 pg/mL) and d-dimer (median 5284 ng/mL) in one cohort of 35 MIS-C patients ( Circulation 2020 May 17 ).
Manifesting as rash, skin peeling, cervical lymphadenopathy, swelling of the hands & feet and gastrointestinal symptoms.Febrile illness characterized by vasculitis.Bears similarities with toxic shock syndrome and Kawasaki disease.May present with fever, elevated serum inflammatory markers and multiorgan involvement, such as rash, abdominal pain and myocarditis ( NYS DOH: Pediatric Multi-System Inflammatory Syndrome Potentially Associated with COVID-19 ).A serious multisystem inflammatory syndrome in children (MIS-C) has been reported (up to 21 years of age).Symptoms may be similar to those of common viral respiratory infections, requiring appropriate suspicion for COVID-19 as well as consideration for other infectious etiologies.Children of all ages are at risk for COVID-19 infection but complications generally appear to be less common than in adults ( CDC: Coronavirus Disease 2019 - Information for Pediatric Healthcare Providers ).Other symptoms include chills, muscle pain, sore throat and loss of taste or smell.