Description
PURPOSE
«ALMUNO-IgM-SARS-CoV-2» Kit is designed for semi-quantitative determination of IgM to nucleocapsid protein of SARS-CoV-2 virus in human blood serum or plasma collected in tubes with EDTA, heparin, citrate for the purpose of COVID-19 diagnosis and differential diagnosis of acute respiratory infection etiology.
The Kit is configured to analyze 46 unknown samples in negative control triplicate, positive control monoplicate. 96 definitions in total. The kit is intended for in vitro use only.
PRINCIPLE OF METHOD
The detection is based on indirect non-competitive ELISA analysis. The test sample and control sample are incubated in the wells coated with the recombinant nucleocapsic protein. Immunoglobulins to this protein when present in the sample bind specifically to the protein immobilized in the wells. Next, IgM- class antibodies are detected with the help of a second antibody in a peroxidase conjugate. After incubation with the substrate and stop reagent application, the optical density of the sample is measured at 450 nm. The measured optical density is directly related to the amount of IgM in the tested and control samples.
CHARACTERISTICS
- sensitivity: 100%.
- specificity: 97.3 %;
- complete ELISA kit;
- 12 months warranty period.
