The immunoenzymatic assay is intended for the diagnosis, monitoring and screening SARS-CoV-2 (COVID-19) infection using IgA antibodies in human serum or plasma in the general population. The semi-quantitative and quantitative semi-automated assay is designed for professional use in a laboratory.
Description:
COVID-19 nucleocapsid recombinant antigen (NP) 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 1 hour 30 min.
High sensitivity and specificity of the test.
Kit includes CUT-OFF, Positive Control, Negative Control and Calibrators (5, 20, 80, 320 U/ml).
Semi-quantitative evaluation in the Index of Positivity (IP) or quantitative evaluation in U/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.
Differentiation between naturally acquired and vaccination antibodies.
Prevalence studies.
Brief assay procedure:
Dilute samples (1:101).
Pipette Controls and diluted Samples.
Incubate at 37°C for 30 min.
Aspirate and wash the wells 5×
Pipette Conjugate.
Incubate at 37°C for 30 min.
Aspirate and wash the wells 5×