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SARS-CoV-2/COVID19 

SARS-CoV-2 Antibody immunochromatographcs test detecting COVID19 IgM/IgG Antibodies.

Product name

SARS-CoV-2/COVID19 IgM/IgG Antibody fast detection kit (Colloidal gold) - PROFI

Intended use

IVD test for IgM and IgG antibodies in blood, i.e. for proving the Coronavirus SARS-CoV-2 infection/ COVID-19 disease. Edition for Health Care Professionals.

Test prionciple

This test is based on fluorescent immunochromatography. The testing kit contains 1) an antigen labelled by colloidal gold and a complex of control antibodies; 2) nitrocellulose membranes with two testing lines (Mand G-line) and one qualitative control line (C-line). The required amount of the sample is dripped into a hole on the test strip. Capillary effects helps the sample run down the nitrocellulose membrane inside the test strip. If the tested sample contains SARS-CoV19/COVID-19 IgM/IgG antibodies, they will be bound to the COVID-19-antigen labelled by colloidal gold and the monoclonal IgM or IgG antibodies will appear on the nitrocellulose membrane as violet-red M- or G-lines. The test will show the sample positivity to IgM or IgG antibodies, thus proving the COVID-19 infection.

Usable biological material

The test has been developed and tested for blood samples testing by the general public. [Additional information for health professionals: Peripheral blood, serum or plasma samples obtained with clinically used anticoagulants (EDTA, heparin, sodium citrate) can be used for the test.]

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)

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 precision depends on the amount of antibodies which is individual. Even if the test is negative, please monitor your health condition. If increased temperature and flulike symptoms persist, repeat the test 24-48 hours later. If respiratory or any other serious complaints occur, or if your health condition does not improve, consult your physician. If you have symptoms and you stayed in infected environment or were in contact with an infected individual, always consult your condition and actions with your physician.

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 page 4.

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 etc.

Cross-reactivity

Tests for IgG / IgM antibodies against the SARS-CoV-2 virus (whole blood / serum / plasma) were analyzed to detect antibodies in positive samples of influenza virus type A, Β, RSV, adenovirus, HBsAg, syphilis, H pylori, HIV and HCV. The results did not show any sign of cross reactivity.

Disruptive substances

The following compounds were tested with the SARS-CoV-2 IgG / IgM antibody test (whole blood / serum / plasma) and no interfering effects were found. Triglycerides: 50 mg / dl, ascorbic acid: 20 mg / dl, hemoglobin 1000 mg / dl, bilirubin: 60 mg / dl, total cholesterol: 6 mmol / l The results did not show cross reactivity.

specificity / sensitivity

96,4% / 99,7%

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