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EPIGENTEK SARS-COV-2

Testing is a crucial factor in being able to control and defeat the COVID-19 outbreak. At EpiGentek, we’ve used our resources to create low-cost COVID-19 / SARS-CoV-2 test kits for healthcare professionals and researchers. This collection of kits is designed to rapidly detect SARS-CoV-2 IgG and IgM antibodies present in blood, serum, or plasma.

The SeroFlash SARS-CoV-2 IgM / IgG Antibody Detection Kit is designed to identify SARS-CoV-2 IgG and IgM antibodies from whole blood or serum samples and can be used in laboratories or by healthcare workers in the point of care. Results can be observed in 15 minutes without special instruments. The kit has the following advantages:

  • Quick method: get results in 15 minutes without special instrumentation.
  • Zero sample preparation: direct detection of whole blood or serum, as well as fingertip/fingerstick blood samples.
  • Two in one: IgG and IgM antibodies are detected simultaneously for additional confirmation, saving costs compared to other methods that detect them separately.
  • High sensitivity: positive test correlation of 97.8% for IgM antibodies in patients with an infection window of 11-24 days; The total approximate precision of both positive and negative correlation with IgG and IgM signals is 92%.
  • High specificity: 100% negative correlation with no cross-reactivity with other human coronaviruses, influenza A / B viruses, and many other viruses *.
  • IgM early detection window: Antibodies can be detected in as little as four days while symptomatic.

The primary components are manufactured under ISO 9001: 2015 and ISO 13485: 2016 standards, and comply with the provisions of the EC Council Directives (DIRECTIVE 98/79 / EC on Medical Devices for In Vitro Diagnosis).

Expected use

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

Background

In the process of infection by pathogenic microorganisms, IgG and IgM are the most widely used markers of infectious disease antibodies. IgM, as the first antibody in the infection process, is often used as a marker of acute infection. With the development of infection, the concentration of IgM 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 cleared. Positive blood can be used as an indicator of infection and previous infection. Therefore, the detection of SARS-CoV-2 IgG and IgM antibodies is of great clinical importance and could effectively control the large-scale transmission of SARS-CoV-2.

Principles of 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 label 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 the SARS-CoV-2 IgM antibody, the G Line is used to test the SARS-CoV-2 IgG antibody, and the Cline is used to check if the sample has been added to the sample hole of the test card. Subsequently, the sample will move along the test card under the action of chromatography.

If the sample contains IgG or IgM antibodies to SARS-CoV-2, the antibodies bind to the gold-labeled virus antigen. The immune complex forms a sandwich complex with the anti-human IgG or IgM monoclonal antibody coated on the G or M line, showing colored bands accordingly and indicates positive IgG or IgM antibodies to SARS-CoV-2. If the G and M test lines do not produce color, a negative result is displayed.

Kit Materials

The kit contains everything you need for 25 tests (blood collection tools or lancets are not included):

  • 25 quick test cards, individually sealed
  • 25 individually sealed disposable sterile transfer pipettes (+1 extra)
  • 25 tubes of Sample Diluent Buffer (+1 extra)
  • Instructions for use

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