Shenzhen GenDo Health Technology Co., Ltd

Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) detects IgM/IgG antibodies in human serum, plasma, whole blood and peripheral blood samples with specific antigen-antibody reaction and colloidal gold immunochromatography. 

When the correct volumn of  sample is added into the sample well of the test cassette, the sample will be absorbed by capillary action. If the sample contains IgM antibody, the antibody will bind with N protein labelled by colloidal gold, and the immune complex will further bind with anti-human IgM antibody coated on the test zone M and form a colored line(test line M), indicating that IgM antibody is positive. 

If the sample contains IgG antibody, the antibody will bind with N protein labelled by colloidal gold, and the immune complex will further combine with anti-human IgG antibody coated on the test zone G and  form a colored line (test line G), indicating that IgG antibody is positive. 

If there is no visible colored line appears on test zone M and test zone G, it indicates a negative result.  

To serve as a quality control, a colored line(control line C) will appear on the control zone C. If there is no visible control line C , the result is invalid and the sample needs to be retested. 

■WARNING AND PRECAUTION 1. This kit is for in vitro diagnostic use only. 2. All samples should be treated as capable of transmitting diseases. Use appropriate precautions in the collection, handling, storage and disposal of patient samples and used kit contents. And follow biosafety level 2 or higher guidelines. 

3. Wear appropriate personal protective equipment (e.g. gowns, gloves, eye protection) when handing the contents of this kit. 4. Proper sample collection storage and transport are critical to the performance of this test. 5. Discard after first use. The test cannot be used more than once. 6. Do not touch the reaction area of test strip. 7. Do not use test kit beyond the expiration date. 8. Do not use the kit if the pouch is punctured or not well sealed. 9. Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical personnel. 10. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 11. All samples and the used-kit has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory regulation. 12. The results should be read immediately after 10min of detection, and the results will be invalid after 20 minutes.