Fact Sheet for Healthcare Providers: Celltrion USA, Inc., Sampinute™ 'COVID-19 Antigen MIA' [open pdf - 171KB]
From the Document: "A positive test result for COVID-19 [coronavirus disease 2019] indicates that antigens from SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC [Centers for Disease Control and Prevention] guidelines. The Sampinute™ COVID-19 Antigen MIA [magnetic Immunoassay] has been designed to minimize the likelihood of false positive test results. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects."
U.S. Food and Drug Administration: https://www.fda.gov/