Application: This product can be widely used in all levels of hospitals, fever clinics, CDC, communities, clinics, counties and other medical and health institutions for pre-checks and triages, enterprises and institutions, schools, airports, high-speed rail stations and other public transportation hubs, and customs inspections Detection of suspected patients such as quarantine. This kit is for medical institution use only.

Features: 【The limitations of the test kit】
1. This product can not be used as the only judgment standard, only as a reference for the comprehensive judgment of doctors.
2. This test paper can only show the qualitative level of IgM antibody produced by the human body after the new coronavirus (2019-ncov) infection in the sample, and cannot be used as the only diagnostic criterion.
3. This product belongs to colloidal gold immunochromatographic test paper, which has the inherent limitations of colloidal gold immunochromatographic method.

【Physical Performance of Products】
1. Phisical appearance: The components in this kit are neat and complete in appearance, no burrs, no damage, no pollution; the material is firmly attached; the label has clear writing and no damage.
2. Film strip width: Film strip width not less than 2.5 mm.
3. Travel speed: Not less than 10mm / min.
4. Negative/Positive coincident Rates: The test contained 5 IgG-positive human serum samples , and the test results showed that IgG was positive; IgM was negative; Comprising detecting IgM-positive human serum samples . 5 sticks, the detection result of IgM show positive; IgG negative; 10 healthy human samples were tested, and the test results were negative for both IgG and IgM.
5. Repeatability: Take any IgM positive sample and test it 10 times, IgM is positive; IgG is negative ; Take any one IgG- positive sample and test it 10 times, IgG is positive; IgM is negative .
6. Minimum detection limit: 1 : 8 dilution of a positive sample, the test result is positive.
7. Inter-batch difference: Extracted three batches novel coronavirus (COVID-19) IgM antibody detection kits, each batch of at least 10 parts of people, repeat positive samples detected at least 10 times . 3 batches of test results should be consistent. Take any one of the negative samples for 10 times and the results are all negative.

This kit uses immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant new coronavirus antigen and quality control antibody gold markers; 2) two detection lines (G and M lines) and one quality Control line (C line) of nitrocellulose membrane. The M line is immobilized with a monoclonal anti-human IgM antibody for detecting a new coronavirus IgM antibody; the G line is immobilized with a reagent for detecting a new coronavirus IgG 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 an IgM antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen. The immune complex will be captured by the anti-human IgM antibody immobilized on the membrane to form a purple-red M line, showing that the new coronavirus IgM antibody is positive.
If the sample contains an IgG antibody, the antibody will bind to the colloidal gold-labeled new coronavirus antigen, and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red G line, indicating that the new coronavirus IgG antibody is positive.
If the test lines G and M are not colored, a negative result is displayed. The test card also contains a quality control line C. The fuchsia quality control line C should appear regardless of whether a test line appears. The quality control line is a color band of the quality control antibody immune complex. 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.