COVID 19 IgM/IgG Antibody test 

European first COVID-19 Antibody IVD test approved for home use under IVD Seelftesting.

Product name

Fast COVID-19 IgM / IgG Antibody Detection Kit (Colloidal gold)

Intended use

IVD test for self-testing for the detection of IgG and IgM antibodies in the blood, thus demonstrating active or overcome COVID 19 infection caused by SARS-CoV-2 virus. The product does not serve as a primary tool for early detection of COVID19! For these purposes, it is necessary to use PCR methods, antigen assays and the like.

Test principle

This kit works on the principle of immunochromatography using colloidal gold. The test kit contains 1) An antigen labelled with colloidal gold and a complex of control antibodies. 2) Nitrocellulose membranes with two test strips (M and G-line) and one quality control strip (C-line) marked. To drop the required amount of sample into the hole on the test strip, the sample will flow over the nitrocellulose membrane inside the test strip due to the capillary effect. If the test sample contains SARS-CoV IgM / IgG antibodies, the antibody will bind to the colloidal gold-labelled SARS-CoV-2 antigen and the antibody complex will render monoclonal IgM antibodies, or monoclonal IgG antibodies on the nitrocellulose membrane as purple-red M, or G lines and thus plots whether the samples are positive for IgM or IgG antibodies and thus demonstrates COVID-19 infection, or provides evidence of past infection and active presence of antibodies in the body.

Usable biological material

The test is developed and tested for the general public for the use of blood samples taken from a finger.

Instructions for use

Open the box, take the primary pack out and let it warm/cool to the room temperature (24 °C). At first, read the whole instructions for use and use the kit immediately after you open the primary pack, however, within maximum 60 minutes after you open the aluminium primary pack !

Test composition (CoV19-PROFI)

ATTENTION! Do not read the test result after more than 10 minutes! The test result can change due to humidity ! The results are invalid after 10 minutes! The results are valid only from minute 3 to minute 10 after the mixture dripping on the plastic testing strip. Let the strip remain in a horizontal position at rest. Do not move or tilt it during the measurement! Use immediately after opening the primary pack! Maintain required volume of samples! Use only droppers supplied in the kit - (1drop = ~20-25ul). HINT: At 10th minute take a photo of the strip/membrane and read the result by zooming the image.

Test results reading

1.Negative result
If the QCC (Quality Control – C) control line is visible and the M- and G-lines are not, the sample is negative because no antibodies were detected. However, continue your health condition monitoring. Retesting 24 hours later is recommended. Do not forget that the amount of antibodies produced in case of a disease is individual and antibodies production is manifested usually by increased temperature. ATTENTION! The test detects the presence of antibodies, but its accuracy depends on the amount of antibodies, which is individual for each person. Even if the test is negative, continue to monitor your health. If fever and flu-like symptoms persist, repeat the test after 24-48 hours. If you experience breathing or other serious problems, or your condition persists, always consult your doctor. If you have symptoms and you have been in an infected environment or have been in contact with an infected person, always consult your doctor about your condition and procedure.

2.Positive test result
2.1 If the control C-line appears together with the M-line, IgM antibody was detected and the sample is positive.
2.2 If the control C-line appears together with the G-line, IgG antibody was detected and the sample is positive.
2.3 If the control C-line appears together with both the G- and M-lines, both IgG and IgM antibodies were detected and the sample is positive. Stay calm in all three cases and read the instructions on next page.

3. Invalid result
If no C-line appears, the test is invalid and must be repeated! It can be due to time delay at testing, reagent contamination, test impairment by temperature, incorrect amount of liquids etc.

specificity / sensitivity