Dia.Pro COVID-19 IgM ELISA Kit

GENERAL INFORMATION Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. Dia.Pro COVID-19 Spike 1&2 IgG ELISA kit is used for the determination of IgG antibodies to COVID-19 Spike antigens in human plasma and serum. As antibodies to Spike glycoproteins, involved in the ACE2 receptor binding, are supposed to be neutralizing by the international Literature, the determination of such IgG is useful to monitor their presence. PRINCIPLE OF THE TEST Microplates are coated with recombinant Spike-1/RBD glycoprotein and Spike-2 antigens specific of COVID-19. The solid phase is first treated with the diluted sample and IgG antibodies are captured, if present, by the antigens. he dispensation of specimens and components is monitored by the DiaPro’s Sample Addition Monitoring System (“SAMS”) where the correct addition of the samples and the reagents of the assay is followed up visually by a step-wise change of colors. After washing out all the other components of the sample, in the 2nd incubation bound antibodies are detected by the addition of polyclonal specific anti hIgG antibodies, labelled with peroxidase (HRP). The enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of anti COVID-19 IgG present in the sample. An index (sample/cut-off) lets optical densities be interpreted into anti COVID-19 Spike specific IgG negative and positive results, and provide a quantification of IgG when present. MATERIALS AND REAGENTS Microplate Negative Control Positive Control Enzyme Conjugate Chromogen/Substrate Sample Diluent Neutralizing Reagent Wash buffer concentrate Sulphuric Acid Plate sealing foils Package insert PERFORMANCE CHARACTERISTICS Diagnostic specificity: The assay was tested on hundreds of samples - a value of > 98% was found. The kit is CE-IVD marked and is included in the database of the Joint Research Center of the European Commission: Dia.Pro COVID-19 ELISA Spike 1 & 2 IgG Kit