COVID-19 SARS-COV-2 IgM/IgG Colloidal Gold Rapid Test

Principle: The principle of immunocapture method is used to detect the new coronavirus IgM antibody and IgG antibody. The nitrocellulose membrane was coated with a mouse anti-human IgM (chain) monoclonal antibody, a mouse anti-human IgG (γ chain) monoclonal antibody, and a goat anti-mouse IgG antibody, respectively. Colloidal gold-labeled recombinant new coronavirus (nCoV) antigen and A murine IgG antibody was used as a tracer. When using, add the sample (sample) to the sample wells of the detection reagent card for detecting IgM antibody and IgG antibody. If the sample contains nCoVIgM antibody, it can be combined with colloidal gold-labeled nCoV antigen to form a complex. The coated mouse anti-human IgM antibody is captured and combined with the mouse anti-human IgM antibody to form a complex with a purple-red band; if the sample contains the nCoVIgG antibody, it can be combined with colloidal gold-labeled nCoV antigen to form a complex The complex binds to a mouse anti-human IgG ( γ chain) monoclonal antibody to form a complex with a purple-red band. The colloidal gold-labeled murine IgG antibody showed a purplish red band on the coated goat anti-mouse IgG antibody as a quality control line.

Test result judgment: 

Observe and record the results for 15 minutes.

IgM antibody positive: A clear purple-red band appears at the positions of T and C lines of the IgM antibody detection reagent reading window, which is judged to be positive for anti-nCoVIgM antibody.

IgG antibody positive: A clear magenta band appears at the T and C lines of the IgG antibody detection reagent reading window, which is judged to be anti- nCoVIgG antibody positive.

Antibody negative: IgM antibody and IgG antibody interpretation window only showed a clear purple-red band at the C line position, which was judged as anti-nCoV antibody negative.

Invalid: There is no fuchsia band at the C line position of the reading window. Regardless of whether the fuchsia band appears at the T line position of the IgM antibody and IgG antibody, the test is invalid. The result is judged within 15 minutes after adding the sample to be tested in the sample hole and the result displayed after 15 minutes is invalid

Detection time: 10-15 minutes

Test samples: whole blood, plasma, serum

Advantages: transportation at room temperature, fast detection time, low laboratory requirements, suitable for large-scale rough screening.

Disadvantages: Prone to false positives

Reagent composition: Test card, sample diluent, desiccant.

Special samples to avoid: Hyperlipidemia serum (triglyceride concentration greater than 25.3mg / ml), bilirubin serum (concentration greater than 0.2mg / ml), hemolytic serum (hemoglobin concentration greater than 5.0mg / ml). Red background and other phenomena may appear, which have certain influence on the judgment of inspection results and should be avoided. Influenza A type IgM antibody, Influenza virus B type IgM antibody, Parainfluenza virus IgM antibody, Mycoplasma pneumoniae IgM antibody, Chlamydia pneumoniae IgM antibody, Respiratory syncytial virus IgM antibody, Adenovirus IgM antibody, Coxsackie virus group B IgM antibody No cross reaction with this product; Influenza virus A type IgG antibodies, influenza virus B type IgG antibodies, parainfluenza virus IgG antibodies, antibody Mycoplasma pneumoniae, Chlamydia pneumoniae IgG , respiratory syncytial virus IgG antibodies, adenovirus IgG antibodies and coxsackie B group IgM antibody of the present No cross-reaction Rheumatoid factor ( RF ), antinuclear antibody ( ANA ), antimitochondrial antibody ( AMA ) have no cross-reaction with this product;