SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit

This test is currently not available in the United States. Not for home or consumer use. For healthcare and research institutions only, please see #D-1001R-025.

The SeroFlash™ SARS-CoV-2 IgM/IgG Antibody Detection Kit 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.

Primary components are manufactured under ISO 9001:2015 and ISO 13485:2016 standards, and meets the provisions of the EC Council Directives (In Vitro Diagnostic Medical Devices DIRECTIVE 98/79/EC).

Intended Use
This product is used for qualitatively identifying IgM and IgG antibodies against SARS-CoV-2 in human whole blood or serum. It is intended for use by healthcare professionals or research scientists only. This product is not to be used for screening donated blood.

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

Clinical Performance
A clinical study with 128 blood samples from 103 confirmed COVID-19 patients and 25 healthy individuals showed the following correlation results: 

Thus, in blood samples, the integrated IgG/IgM test can detect at a 97.78% accuracy rate for patients with an infection window of 11-24 days, and an 84.48% accuracy rate for patients with an infection window of 4-10 days. The total accuracy of positive and negative correlation for an infection window of 4-24 days is 92.19%.

An additional clinical study with 225 serum samples from 130 confirmed COVID-19 patients and 95 healthy individuals showed the following correlation results:

Thus, in serum samples, the integrated IgG/IgM test can detect at a 86.96% accuracy rate for patients with an infection window of 11-24 days, and an 86.89% accuracy rate for patients with an infection window of 4-10 days. The total accuracy of positive and negative correlation for an infection window of 4-24 days is 92.00%.

Please note the following:

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• Not for the screening of donated blood.

The current lot is 2004003. View the Certificate of Analysis for this lot.