ELISA Kits IgM

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 IgM ELISA kit is used for the determination of IgM antibodies to COVID19 in human plasma and serum. The kit is intended for the monitoring of the immune response to COVID-19, in particular in the early stage of the infection as its marker in addition to PCR.Enzyme-linked immunosorbent assays (ELISAs) are more rapid serology tests that provide a readout of antigen-antibody interactions. Essentially, patient antibodies are “sandwiched” between the viral protein of interest and reporter antibodies, so that any active patient antibodies are detected. PRINCIPLE OF THE TEST Microplates are coated with immunodominant recombinant antigens specific to COVID-19. The solid phase is first treated with the diluted sample in presence of a RF blocking reagent; IgM are captured, if present, by the antigens. 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 hIgM 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 IgM present in the sample. A cut-off value let optical densities be interpreted into COVID-19 IgM negative and positive results. 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. Precision: It has been calculated on two samples, one negative and one low positive, examined in 16 replicates in three separate runs. The variability did not lead in sample misclassification. The kit is intendedfor “in vitro” diagnostic use only.