The SeroFlash™ SARS-CoV-2 IgM/IgG Antibody Detection Kit, from EpiGentek, is designed for identifying IgG and IgM antibodies of SARS-CoV-2 from whole blood or serum samples and can be used in laboratories or by point-of-care healthcare workers. The results can be observed within 15 min without any special instruments. The kit has the following advantages:

• Rapid Method: Obtain results within 15 minutes without special instrumentation.
• Zero Sample Prep: Detection directly from whole blood or serum, as well as fingertip/fingerstick blood samples.
• Two-In-One: Both IgG and IgM antibodies are simultaneously detected for additional confirmation, saving on costs versus other methods that detect them separately.
• High Sensitivity: 97.8% positive test correlation for IgM antibodies in patients with an infection window of 11-24 days; Total approximate accuracy of both positive and negative correlation with IgG and IgM signals is 92%.
• High Specificity: 100% negative correlation without cross-reactivity to other human coronaviruses, influenza A/B viruses, and many other viruses*.
• Early Detection Window of IgM: Antibodies can be detected in as early as four days while symptomatic.

Ordering information

Background
In the process of pathogenic microorganism infection, IgG and IgM are the most commonly used antibody markers of infectious diseases. IgM, as the first antibody in the process of infection, is usually used as a marker of acute infection. With the development of infection, IgM concentration gradually decreases and disappears after the appearance of IgG. IgG usually exists in the body for a long time, even if the virus has been completely eliminated. Positive blood can be used as an indicator of infection and previous infection. Therefore, detecting SARS-CoV-2 IgG and IgM antibodies is of great clinical significance and could effectively control large-scale transmission of SARS-CoV-2.

Principles of the Technology
This kit uses lateral flow colloidal gold-based immunoassay technology by spraying colloidal gold-labeled recombinant SARS-CoV-2 antigen and a control antibody gold marker on a binding pad. Two test lines, G and M, and a control line C on the membrane are coated with mouse anti-human IgG (G), mouse anti-human IgM (M), and a quality control antibody (C), respectively. The M line is used to test for SARS-CoV-2 IgM antibody, the G line is used to test for SARS-CoV-2 IgG antibody, and the C line is used to check if the sample has been added to the sample hole of the test card. The sample will subsequently move along the test card under the action of chromatography. If the sample contains SARS-CoV-2 IgG or IgM antibodies, the antibodies bind to the gold-labeled virus antigen. The immune complex forms a sandwich complex with the coated anti-human IgG or IgM monoclonal antibody at the G or M line, showing colored bands accordingly, and indicates positive IgG or IgM antibodies for SARS-CoV-2. If the test line G and M do not produce color, then a negative result is displayed.

Kit Materials
The kit contains everything needed for 25 tests (blood collection tools or lancets are not included):

• 25 Rapid Test Cards, Individually Sealed
• 25 Disposable Sterile Transfer Pipettes, Individually Sealed (+1 extra)
• 25 Tubes of Sample Diluent Buffer (+1 extra)
• Instructions for Use