The immunoenzymatic assay is intended for the diagnosis, monitoring and screening SARS-CoV-2 (COVID-19) infection using IgG antibodies in human serum, plasma or dry blood spot in the general population. The semi-quantitative and quantitative manual assay is designed for professional use in a laboratory.
Description:
Recombinant antigen Receptor-binding domain (RBD), a subunit of the Spike S1 protein, is bound to the well surface of the microtiter plate.
If specific antibodies are present, they bind to the antigen, are labeled by the Conjugate in the following steps and are detected by color reaction with a single component substrate (TMB-Complete).
The kit allows 96 tests, including controls in a split microtiter plate with color-coded strips and breakable wells.
Advantages:
The total assay time is about 2 hours.
High sensitivity and specificity of the test.
Kit includes CUT-OFF, Positive Control, Negative Control and Calibrators (5, 20, 80, 320, 640, 1000 BAU/ml).
Semi-quantitative evaluation in the Index of Positivity (IP) or quantitative evaluation in BAU/ml.
Ready-to-use, color-coded components.
Single-component substrate.
Interchangeable components with the exception of kit specific components (Controls, Conjugate, Plate).
Application:
Identification of patients with asymptomatic infection in the past.
Detection of naturally acquired and vaccination antibodies.
Prevalence studies.
Indication of neutralizing immunity.