Cost Effective Rapid Test Device MSLDNA01

INTENDED USE 
The Novel coronavirus neutralizing antibody Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibody of Coronavirus Disease 2019 in human whole blood,serum,or plasma as an aid in the Evaluation levels of human anti-novel coronavirus neutralizing antibody titer.

PRINCIPLE
This kit uses immunochromatography. The test card contains:1)colloidal gold-labeled recombinant novel coronavirus S-RBD antigen, refer control and quality control antibody gold markers; 2) one detection line(T line), one reference line(R line) and one quality Control line (C line) of nitrocellulose membrane.

The T line is immobilized with Human ACE2 protein for detecting novel coronavirus neutralizing antibody;the R line is immobilized with reference control antibody; and the C line is immobilized with a quality control antibody.

When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. 

The rest gold-labeled novel coronavirus antigen in immune complex will be captured by the human ACE2 protein immobilized on the membrane to form a purple-red T line,the intensity of t line Inversely proportional to the concentration of antibody.

The test card also contains a quality control line C and a reference line R.The fuchsia quality control line C and reference control line R should appear regardless of whether a test line appears.If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.