Sars-COV-2

CORONAVIRUS TEST

DESCRIPTION

COVID-19 IgG/IgM Rapid test (whole blood / serum / plasma) is a chromatographic immunoassay to test IgG and IgM antibodies of the SARS-CoV-2 virus in human whole blood, serum or plasma samples to determine primary or secondary infection.

The test membrane is covered with a specific, colloidal gold particles conjugated with non human IgG and IgM antigenes.

These rapid tests for detecting SARS-CoV-2 antibodies are based on a colloidal gold immunochromatographic assay to detect a presence of SARS-CoV-2 antibodies. Colloidal gold marked goat anti-chicken IgY polyclonal antibody and recombinant SARS-CoV-2 antigen are coated in reagent conjugate pad. Mouse anti-human IgG monoclonal antibody and mouse anti-human IgM monoclonal antibody are coated in detection area of nitrocellulose membrane. Chicken IgY is coated in control area.

CLINICAL EVALUATION

SENSITIVITY (serum, plasma)
96.3%
SENSITIVITY (whole blood)
95%
SPECIFITY (serum, plasma)
99.6%
SPECIFITY (whole blood)
99.2%

During test, specific SARS-CoV-2 antibody in blood sample conjugates with colloidal gold marked recombinant SARS-CoV-2 antigen to form immune complex. Owing to capillary action, immune complex flow across the membrane. If blood sample contain specific SARS-CoV-2 antibody, it will be captured by the test area coated mouse anti-human monoclonal antibody and form a visible line in test area (test line). Excess colloidal gold marked goat anti-chicken IgY polyclonal antibody keeps moving, specific binding with control area coated Chicken IgY and from a visible line in control area (control line). If blood sample doesn’t contain SARS-CoV-2 antibody, only control line will be appeared.

STARTS AT 6€

FOR A SINGLE TEST

15 MINUTES

TO GET A RESULT

100%

REPEATABILITY

PRZEPROWADZANIE BADANIA

  1. Preparation:
    1. Allow the test strip and sample to reach the room temperature.
    2. Check the strip’s expiration date. Do not use expired test strips.
    3. Take a strip out of the foil bag and place it on a dry and level surface.
  2. Testing:
    1. Adding the sample:
      Insert dropper slantwise into blood collection tube (within 0.5cm), gently touch the sample to absorb sample. Dropper will automatically absorb needed amount of sample (10μL). Do not press on the top of dropper when absorbing samples. Next gently touch sampling area on strip with the dropper and squeeze the top of dropper to add the whole sample.
    2. Gently squeeze the dropping bottle containing sample diluent, add 2~3 drops of diluent vertically into the sampling area (see picture).
    3. Wait for 15~20 minutes and observe the results. Results are invalid if they appeared after 20 minutes.

EXPLAINATION OF THE RESULTS

PRESENTATION OF PERFORMING A TEST