Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Assay Kit (Colloidal Gold)
- Very quickly to know the result
- CE mark
- Antibody lgG/lgM type
The kit is intended for the in vitro qualitative determination of Novel Coronavirus (2019-nCoV) IgG/IgM antibody in human serum, plasma or whole blood. Testing is limited to supplementary detection indicator for suspected nucleic acid negative results or in conjunction with nucleic acid detection in the diagnosis of suspected cases. It should not be used as the basis for diagnosis and exclusion of Novel Coronavirus Pneumonia. It is not suitable for general screening.
For medical institutions use only.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Further confirmation is needed for positive results. Negative results do not rule out of the possibility of infection.
This product is only used for clinical and emergency stockpile in the period of pneumonia outbreak caused by Novel Coronavirus since December 2019, not used as conventional in vitro diagnostic reagent for clinical use. The test results of this kit are for clinical reference only. It is suggested to be comprehensively analyzed based on the clinical manifestation of patient and other laboratory results.
Laboratory testing of Novel Coronavirus (2019-nCoV) should be in accordance with the Technical Guidelines for Laboratory Testing of Novel Coronavirus(2019-nCoV) Pneumonia Infection to do a better bio-safety job.
【PRINCIPLE OF THE PROCEDURE】
The Novel Coronavirus (2019-nCoV) Antibody IgG/IgM test is performed using the Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Assay Kit on Colloidal gold-Immunochromatographic system. The detection card contains: 1) Recombinant antigen of Novel Coronavirus (2019-nCoV) labeled by Colloidal gold and Colloidal gold-labeled rabbit IgG antibody. 2) Nitrocellulose membrane coated by two detection lines (T1 line and T2 line) and one quality control line(C line).T1 line is coated by anti-human monoclonal IgG antibodies. T2 line is coated by anti-human monoclonal IgM antibodies. C line is coated by goat anti-rabbit IgG antibodies.
Add defined amount of specimens into the sample hole of detection card. The antibody IgG/IgM to specimens react with the Novel Coronavirus (2019-nCoV) antigen labeled by colloidal gold. After reacting, the immune complexes are formed. The complexes captured by the anti-human IgG/IgM antibodies pre-coated on the nitrocellulose membrane, then a purple T1/T2 line appears. This shows “Positive” for antibody IgG/IgM to Novel Coronavirus (2019-nCoV).
Detection Card of Novel Coronavirus (2019-nCoV) Antibody IgG / IgM
Sample Dilution Buffer
1 × 3.0mL
1 × 3.0mL
1 × 3.5mL
Note: The components in the kits of different batches cannot be mixed to avoid erroneous results.
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