【Packaging specifications】
1 test/kit、20 tests/kit、40 tests/kit、100tests/kit
Product features：
(1) Test samples: serum and plasma;
(2) Rapid screening of coronavirus within 15 minutes;
(3) No equipment, suitable for on-site screening;
(4) Reduce the risk of individual infection in hospital;
(5) Early diagnosis, early treatment, shorten the course of disease;
(6) Reduce the workload of designated hospitals.
【Expected Usage】
This Kit is suitable for qualitative detection of novel coronavirus (SARS-CoV-2) IgM and IgG antibodies in human Serum, plasma, and whole blood in vitro. Common signs of a person infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure, and even death. Coronavirus can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets.
【Detection Principle】
This kit uses the principle of immunochromatography: the separation of components in mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Inside the box is a dry culture medium, coated from top to bottom control antibody (“C” control line) (Figure 1) and mouse anti-human IgG monoclonal antibody (“IgG” test line), mouse anti-human IgM monoclonal antibody (“IgM” test line) . The novel coronavirus recombinant antigen (NCRA) is in the release pad section. Once diluted serum, plasma, or whole blood is applied to the release pad section, the NCRA will bind to coronavirus IgM/IgG antibodies if they are present, forming an NCRA-IgM/IgG complex. The sample and antibodies will then move across the cassette’s medium via capillary action. If coronavirus IgM antibody is present in the sample, the test Line (T) will be bound by the IgM-IgM or IgG-IgG complex and develop color. If there is no coronavirus IgM/IgG antibody in the sample, free NCRA will not bind to the test line (T) and no color will develop. The free NCRA will bind to the control line ( C ), the control line should be visible after the detection step as this confirms that the kit is working properly.
【Assay Procedure】
1.Sample Preparation
Before the test, the test card, sample and sample diluent should be restored to room temperature (20℃~30℃). It is recommended to open the test card after restoring the room temperature, and use it within one hour as soon as possible to prevent the test card from getting damp.
2.Testing Method
Place the test card on the test bench, use the pipette to absorb 20 μL of samples to be tested, drop them into the test card sample hole, and then add 2 drops of sample diluent to the test card sample hole with the drop bottle.
3.Observing Results
Read the results in 15 minutes. To ensure the accuracy of the results, do not read the results after 15 minutes.
