Description
PURPOSE
«ALMUNO SARS-CoV-2 AG» Kit is designed for the rapid determination of SARS-CoV-2 antigen (nucleocapsid protein) in clinical samples (nasopharyngeal swabs, nasopharyngeal swabs in transport media) for the diagnosis of coronavirus disease (COVID), differential diagnosis of the etiology of acute respiratory infection.
The test makes it possible to obtain quick and reliable result on the presence of coronavirus infection in large segments of the population and is a valuable alternative to molecular diagnostic methods. The kit is intended for in vitro use only.
PRINCIPLE OF METHOD
The detection is based on the principle of immunochromatographic analysis. Monoclonal antibodies to the SARS-CoV-2 nucleocapsid antigen have been immobilized in the test zone of the nitrocellulose membrane. Monoclonal antibodies to the SARS-CoV-2 nucleocapsid antigen, labeled with colored microparticles, are applied to the conjugate substrate. The analyzed sample is absorbed by the absorbent section of the test strip. During the analysis, the antigen from the sample binds to specific antibodies surfaced on the microparticles and to antibodies immobilized in the test zone. The result of their interaction is a complex visible in the form of a color line.
CHARACTERISTICS
- sensitivity: 92.9 %;
- specificity: 99.6 %;
- quick results within 10 minutes;
- no additional equipment is required;
- the possibility to use nasopharyngeal swabs taken in transport medium without additional dilution;
- 24 months warranty period.
