WHAT IS IT?
An antibody test that is an in vitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma.
HOW TO ADMINISTER
The box contains a test cassette, a bottle of buffer, a disposable lancing device, an alcohol wipe, a micropipette.
- Take the test kit out of the box and leave at room temperature, in the room where the test will be carried out, for at least 30 minutes (ensure the surface is clean and completely dust-free surface)
- Use the lancing device (is there another name for this?) to bring out a drop of blood from your fingertip
- Put the drop into the well, reserved for blood.
- Add two drops of buffer (contained in a small bottle).
- After fifteen minutes, read the result
- Consult the accompanying leaflet to ensure the correct reading of the result
WARNINGS, PRECAUTIONS AND LIMITS OF USE
- The IgM / IgG antibody results obtained from the test CANNOT be used as the sole basis for diagnosis or to rule out a SARS-CoV-2 infection or as information on the status of the infection.
- Negative results do not rule out SARS-CoV-2 infection particularly in individuals who have been in contact with the virus. To rule out infection in rapid test positive individuals, follow-up testing with molecular diagnostics and / or CT should be considered.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains such as HKU1, NL63, OC43, or 229E coronavirus. Follow-up tests with molecular diagnostics and / or CT should be considered to confirm the rapid test result.
- This quick test is not intended for home use.
- This rapid test is not intended for screening of donated blood.
- Do not use highly haemolytic samples.
- Further molecular diagnostics and / or CT is recommended to identify the actual physical situation
- Do not reuse the same test. Do not use the kit beyond the expiration date.
- Use only human whole blood (taken from vein or fingertip), serum or plasma as a sample. Follow the leaflet for accurate results.
- All parts of the kit are considered biohazardous and potentially transmit infectious diseases from bloodborne pathogens even after cleaning and disinfection have been performed. Use appropriate precautions and follow all applicable regulations when disposing of used test kits.
PROCEDURE FOR CARRYING OUT THE TEST
Allow the kit and the buffer to equilibrate at a temperature between 15 ° and 30 ° C before starting the test.
- Place the device on a flat and clean surface.
- Insert 10 μL of whole blood (taken from vein or fingertip), serum or plasma into the well on the device.
- Add 2 drops (approximately 60-80 μL) of buffer into the well on the device
- Read the test result at the 15th minute. Do not read the result after 20 minutes.
Note: Handle the buffer carefully, avoid any contact with eyes or skin. In case of contact with eyes or skin: wash with plenty of water.
INTERPRETATION OF RESULTS
1. Positive result:
SARS-CoV-2 IgM antibody positive:
Quality control C-band and IgM band both colour and appear, while the IgG band does not colour and does not appear.
SARS-CoV-2 IgG antibody positive:
Quality control C band and IgG band both colour and appear, while the IgM band does not colour and does not appear.
SARS-CoV-2 IgM and IgG antibodies positive:
All 3 bands appear, that C of quality control and those of IgG and IgM.
2. Negative result:
Only the C band for quality control is coloured and appears without other lines appearing for the detection of IgM or IgG. This indicates that the test result is negative for both IgM antibodies and SARS-CoV-2 IgG.
3. Invalid result:
The C band for quality control does not appear indicating that the test is not valid regardless of whether the lgG and lgM bands are coloured or not. You will need to collect a new sample and perform another test with a new kit.
Internal procedural checks are included in the test. A coloured band that appears in the control area (C) is an internal procedural control and confirms that the sample volume is sufficient and the correct procedural technique. Control standards are not provided with this kit; however it is recommended to test the positive and negative controls as good laboratory practice to confirm the test procedure and to verify the performance of the test.