This kit is based on the principle of immunochromatographic testing and uses the capture method to detect SARS-CoV-2 IgG antibody and SARS-CoV-2 IgM antibody in the sample. When the sample contains SARS-CoV-2 IgG and IgM antibody, it forms a complex with fluorescently labeled protein (SARS-CoV-2 recombinant RBD protein). The complex proceeds under the influence of chromatography and the antibody coated on the M line combines with the Mouse anti-human IgM monoclonal antibody, which is an IgM positive result. Next, the antibody coated on the G line, an IgG positive result, conjugates with the Mouse anti-human IgG monoclonal antibody. When the sample does not contain SARS-CoV-2 IgG antibody and SARS-CoV-2 IgM antibody, no complex can be formed on the M line and G line, and the red band does not appear, which is an IgM negative result and an IgG negative result. Regardless of whether SARS-CoV-2 IgG and IgM antibody is present in the sample, the fluorescently labeled protein (SARS-CoV-2 recombinant RBD protein) will bind with the coated antibody (goat anti-mouse IgG antibody). C line (C line) to form a complex. The dedicated analyzer can read the results when the reaction is finished. The optical density of the control line and test line will be analyzed by the analyzer, the SARS-CoV-2 Spike Protein concentration will be calculated with the preset calibration curve, and the results will be displayed with the unit S/CO.
1.This product is only used for testing serum, plasma samples.
2.If the result is Negative, COVID-19 infection is possible.
3.Test results for this product are for clinical reference only and should not be the sole basis for clinical diagnosis and treatment. Clinical management of patients should be combined with symptoms, physical signs, medical history, other laboratory tests (especially etiology testing), treatment response and epidemiology, and other information.
4.The reference value of serological antibody detection is limited for patients with impaired immune function or receiving immunosuppressive therapy.
5.IgG and IgM antibody positivity causes not only primary infection but also secondary infection.
6.The product detects SARS-CoV-2 IgG and IgM antibody in the sample, SARS-CoV-2 is not directly reflected in the samples.
7.SARS-CoV-2 IgGand IgM antibody tests are not a diagnosis of an active disease.
It does not show immunity to SARS-CoV-2 infection or SARS-CoV-2 virus.
