2019-nCoV rapid test

Product Description:

The kit is used for the qualitative detection of novel coronavirus (2019-nCoV) IgM antibodies in human serum and plasma samples in vitro. It is only used as a supplementary detection index for suspected negative cases of new coronavirus nucleic acid detection, or in collaboration with nucleic acid detection in the diagnosis of suspected cases, and can not be used as a basis for the diagnosis and elimination of pneumonia caused by new coronavirus infection.

The test results are positive and need further confirmation. Negative results can not exclude the possibility of infection.

Features:

• Product Name:2019-nCoV rapid test
• Shelf Life: 24 Months
• Format: Kit
• Storage Temperature: 2-30°C
• Applications: Medical Diagnosis
• Country of Origin: China

Technical Parameters:

Inspection principle:

The kit is based on colloidal gold immunochromatographic technique, which is used for the qualitative detection of new type of coronavirus (2019-nCoV) IgM antibodies in serum and plasma samples. Colloidal gold labeled mouse anti human IgM (μ) monoclonal antibody was used on the gold label pad. The recombinant novel coronavirus (2019-nCoV) Np antigen was coated on the nitrocellulose membrane as the detection area of IgM antibody (T line), and the Goat anti mouse IgG polyclonal antibody was used as the quality control area (C line).When the appropriate sample was added to the sample hole of the detection card, the sample will move forward under the action of chromatography. If the sample contains a new coronavirus IgM antibody, the antibody can be combined with mouse anti human IgM (μ) monoclonal antibody labeled with colloidal gold to form an immune complex. The immune complex will continue to flow forward inside the nitrocellulose membrane under chromatography. When the immune complex passes through the detection area of IgM antibody, it will be trapped and agglutinated by the Np antigen on the nitrocellulose membrane. If there is no new coronavirus IgM antibody in the sample, It is impossible to form an immune complex so that the chromogenic color can not be detected in the corresponding detection area. Free colloidal gold labeled mouse anti human IgM (μ chain) monoclonal antibody will also flow forward inside the nitrocellulose membrane under chromatography and combine with the Goat anti mouse IgG polyclonal antibody coated with the quality control area (C line) and coagulate and color. Negative samples only show color on line C.

Main components:

1.2019-nCoV IgM detection card (T line wrapped by recombinant novel coronavirus (2019-nCoV) Np antigen, C line coated with Goat

anti mouse IgG polyclonal antibody, buffer: 0.05mol/L PBS pH7.4; Gold label pad wrapped by colloidal gold labeled mouse anti human IgM (μ) monoclonal antibody): 1 human X 5 (5 tests / box), 1 person x 20 (20 tests / box), 1 person x 40 (40 tests / box).

2.Sample diluent (0.01M PBS): 1 bottles x 1 ml (5 tests / box), 1 bottles x 3 ml (20 tests / box), 1 bottles x 6 ml (40 tests / box).

Sample requirements

• Serum and plasma samples were collected from the venous blood by conventional method. The treatment of plasma sample: heparin solution, sodium citrate solution and EDTA solution can be used to anticoagulate blood.
• Serum or plasma samples can be stored at 2 ~ 8 ℃ if tests will be done within 5 days, otherwise stored at -20 ℃. No more than 3 times of freeze-thaw.
• The result of haemolysis sample test is invalid.
• Samples containing suspended fibrin or polymer are recommended for centrifugation and supernatant for testing. Hemolytic samples can not be detected.
• There should be no other microbial contamination in the samples to be tested.
• The specimen transfer box should have special identification. After removing the specimen from the sealed bag, it must be sterilized by ultraviolet or 75% ethanol spray.
• Before use, the sample should be kept at room temperature for more than 30 minutes, and the sample should be mixed before freezing.

Serum or plasma samples can be inactivated by heat, and the results are stable after thermal inactivation.