Enzyme Linked Immunosorbent Assay (ELISA) for the quantitative detection of IgG antibodies to SARS-CoV-2in human serum or plasma. It is intended for evaluating the immune response of patients suspected to be infected by SARS-CoV-2, for seroepidemiologic studies and as an aid in the diagnosis of Coronavirus disease 2019 (COVID-19). Positive results can help to qualifypeople to donate blood that can be used to manufacture convalescent plasma for those who are seriously ill from COVID-19. The serological test will be used for the monitoring of the immunological response upon vaccination (when available). For “in vitro” diagnostic use only.
Introduction
SARS-CoV-2 is a new strain of Coronavirus that was first identified during an outbreak in Wuhan, China, in December 2019. Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are named for their crown-like appearance when imaged. The large, type I transmembrane spike glycoprotein accounts for this notable feature. It is a heavily-glycosylated, cell-surface protein which is thought to mediate viral entry into susceptible cells. This spike glycoprotein, called ‘S’, is trimeric in structure. In addition to the S protein, there are three other structural base proteins: the envelope, membrane, and nucleocapsid. The S protein has two distinct functional domains, termed S1 and S2, both of which are necessary for a Coronavirus to successfully enter a cell.SARS-CoV-2 is the ethiological agent of COVID-19 respiratory disease.