Description
PURPOSE
«ALMUNO-AG-SARS-CoV-2» Kit is intended for the determination of SARS-CoV-2 antigen (nucleocapsid protein) in clinical samples (nasopharyngeal swab, oropharyngeal swab) for the diagnosis of coronavirus infection and differential diagnosis of acute respiratory infection etiology. On the basis of this information it is possible to draw conclusions about:
- the presence of a coronavirus (COVID-19) infection;
- the effectiveness of therapy against coronavirus (COVID-19) infection.
The kit is designed for 96 determinations, including staging in triplicate of the negative control and in monoplicate of the positive control. The kit is intended for in vitro use only.
PRINCIPLE OF METHOD
The detection is based on an indirect, non-competitive sandwich ELISA. The kit uses monoclonal antibodies that are specific to two different epitopes of the SARS CoV-2 nucleocapsid protein molecule and do not compete with each other. The test and control samples are incubated in the wells of the plate with the immobilized first monoclonal antibody in the presence of the second monoclonal antibody labeled with horseradish peroxidase. After incubation with the substrate and the application of the stop reagent, the optical density of the solution is measured. The measured optical density is directly related to the amount of antigen in the control and test samples.
CHARACTERISTICS
- sensitivity: 92.2 %;
- specificity: 100%;
- complete ELISA kit;
- 12 months warranty period and support.
BENEFITS
- no sample preparation step;
- single-stage analysis;
- compatibility with almost all transport media;
- higher sensitivity and specificity compared to rapid tests;
- false positive results are completely excluded;
- possibility of automatization for high performance laboratories;
- the cost of one study is lower than when using rapid tests.
