Clinical Resources:
SARS-CoV-2 IgM/IgG
Antibody Assay Kit

Test Principle

This product adopts colloidal gold immune-technology, spraying colloidal gold-labeled recombinant novel coronavirus antigen and quality-control antibody gold marker on the binding pad; the nitrocellulose membrane is coated with two test lines (G and M) and a control line (C). The M line is coated with mouse anti-human IgM monoclonal antibody, which is used to detect novel coronavirus IgM antibodies. The G line is coated with mouse anti-human IgG monoclonal antibody, which is used to detect novel coronavirus IgG antibodies. The C line contains quality-control antibodies. When the novel coronavirus sample is added to the sample hole of the test card, the sample will move along the test card under the action of chromatography. If the sample contains the novel coronavirus IgM antibody, the antibody binds to the gold-labeled virus antigen.

The immune complex forms a sandwich complex with the coated anti-human IgM monoclonal antibody at the M line, showing a purplish red M line and indicating positive IgM antibody for the novel coronavirus. If the sample contains the novel coronavirus IgG antibody, it binds to the gold-labeled novel coronavirus antigen. The immune complex forms a sandwich complex at the G line with the enveloped murine anti-human IgG monoclonal antibody, showing a purplish red G line and indicating that the novel coronavirus IgG antibody is positive. If the test lines (G and M) do not produce color, the negative result is displayed. The card also contains a control line (C). The magenta control line should appear in every valid test, indicating that the test is properly performed and that reagents are functional as specified. If the control line does not appear, it means that the test result is invalid, and the sample should be tested again.

test-principle
assay-clinical-study-result-20200811-v2

Assay Clinical Study Result

Overall IgM and IgG: The overall positive percent agreement (PPA) was 90.00%, and the 95% confidence interval was (78.64%, 95.65%). Overall negative percent agreement (NPA) was 97.00%, and the 95% confidence interval was (91.55%, 98.97%); the overall percent agreement was 94.67%, and the 95% confidence interval was (89.83%, 97.27%).

Total IgM: IgM positive percent agreement (PPA) was 80.00%, and the 95% confidence interval was (66.96%, 88.76%). IgM negative percent agreement (NPA) was 97.00%, and the 95% confidence interval was (91.55%, 98.97%).

Total IgG: IgG positive percent agreement (PPA) was 90.00%, and the 95% confidence interval was (78.64%, 95.65%). IgG negative percent agreement (NPA) was 97.00%, and the 95% confidence interval was (91.55%, 98.97%).

Frequently Asked Questions

For specific questions on the topics above, please reach us directly at info@freedomtestkit.com.