Diagnostic Kit for IgM/IgG  Antibody to 2019-nCoV
(Colloidal Gold)

Catalog No.: BG1903C                                             

【Packing specification】

5 test cards/ box,20 test cards/ box, 40 test cards/ box

【Intended Use】

The kit is used for the qualitative detection of a novel coronavirus (2019-nCoV) IgM/IgG antibody in human serum, plasma or whole blood 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.

【Main components】

1.2019-nCoV IgM/IgG detection card (T1 line coated with mouse anti human IgG (γ) monoclonal antibody, T2 line wrapped by mouse anti human IgM (μ) monoclonal antibody, 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 recombinant antigen（NP and S） of coronavirus (2019-nCoV)): 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).

【Inspection method】

1.Pretest preparation: 10μL, 50μL and 100μL micropipette 1 and matched suction heads or dropper (10μL, 50μL, 100μL).
Inspection process: Put the detection card on the dry horizontal worktable. Add 10μL serum or 20μL whole blood sample into the sample well using the micro pipette, then add two drops(about70~100μL) of sample dilution immediately. Observe the result in 10~15 minutes after the serum or plasma samples added. The observation is invalid after 15 minutes.

3.  Precautions in the inspection process:
a. The kit and the samples to be tested should be placed in equilibrium at room temperature before they can be inspected.
b. Be attention to the potential biological risks. Wearing necessary protective equipments, and dealing with waste as infectious material.

【Interpretation of test results】

Only C line showed color: negative;
 C line and T2 line all showed color: new coronavirus IgM antibody positive;
 C line and T1 line all showed color: new coronavirus IgG antibody positive; C line, T2 line, T1 line all showed color: new coronavirus IgG antibody and antibody were positive at the same time. 
If no C line is developed, the assay is invalid regardless of any color in   the T1 line and T2 line. Re-detection if the detection result is invalid.
Note: Samples should be processed according to infectious contaminants and samples should be collected again.