Description
Iris SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) is a rapid test for the qualitative detection of IgM and IgG antibodies against SARS-CoV-2 in human whole blood (collected from a vein or fingertip), serum, or plasma. The test is for in vitro diagnostic use only and for professional use only. It is intended for clinical laboratories and for use by healthcare professionals for testing performed at point-of-care settings only. It is not intended for home testing. VivaDiagTM SARS-CoV-2 IgM/IgG Rapid Test is based on immunoassay technology.
The device contains:
1) Conjugate pad: recombinant SARS-CoV-2 antigen conjugated with colloidal gold bound to FITC, FITC antibodies, and quality control antibodies labeled with gold.
2) Nitrocellulose membrane: equipped with two detection bands (IgG band and IgM band) and one quality control band (C band). The IgM band, coated with anti-human rat monoclonal IgM antibodies, detects anti-SARS-CoV-2 IgM antibodies. The IgG band, coated with anti-human rat monoclonal IgG antibodies, detects anti-SARS-CoV-2 IgG antibodies. The C band is coated with quality control antibodies.
When the blood/serum/plasma sample is introduced into the device's well, it will react with the reagents inside the device. If the sample contains IgM antibodies, it will bind to the colloidal gold-labeled viral antigen to form a sandwich complex with the anti-human IgM monoclonal antibody coated on the IgM band. The IgM band will appear purple-red, indicating that the SARS-CoV-2 IgM antibody is positive. If the sample contains IgG antibodies, it will bind to the colloidal gold-labeled viral antigen to form a sandwich complex with the anti-human IgG monoclonal antibody coated on the IgG band. The IgG band will appear purple-red, indicating that the SARS-CoV-2 IgG antibody is positive.
If neither the IgG nor IgM bands color, the test result will be negative. The test also contains the C band for quality control, which will appear purple-red if the test is valid. If the C band for quality control does not appear, the test will not be valid even if the IgM and/or IgG detection bands appear.
Materials required but not supplied: sterile lancet (for fingertip blood), alcohol swab, clock/timer.

Instructions for use
Allow the kit and buffer to equilibrate to a temperature between 15° and 30°C before starting the test.
1. Place the device on a clean, flat surface. 2. Insert 10 mcl of whole blood (collected from a vein or fingertip), serum, or plasma into the well on the device.
3. Add 2 drops (approximately 60-80 mcl) of buffer into the well on the device.
4. Read the test result at 15 minutes. Do not read the result after 20 minutes.
1. Positive result:
SARS-CoV-2 IgM antibody positive: both the quality control C band and the IgM band color and appear, while the IgG band does not color and does not appear.
SARS-CoV-2 IgG antibody positive: both the quality control C band and the IgG band color and appear, while the IgM band does not color and does not appear.
SARS-CoV-2 IgM and IgG antibodies positive: all 3 bands appear: the quality control C band and both the IgG and IgM bands.
2. Negative result:
Only the quality control C band colors and appears without any other IgM or IgG detection lines appearing. This indicates that the test result is negative for both SARS-CoV-2 IgM and IgG antibodies.
3. Invalid result:
The quality control C band does not appear, indicating that the test is invalid regardless of whether the IgG and IgM bands color or not. A new sample will need to be collected, and another test performed with a new kit.

Warnings
IgM/IgG antibody results obtained from the test CANNOT be used as the sole basis for diagnosis or to rule out SARS-CoV-2 infection or as information on the infection status. Negative results do not rule out SARS-CoV-2 infection, especially in individuals who have been in contact with the virus. To rule out infection in individuals positive for the rapid test, follow-up tests 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 coronavirus HKU1, NL63, OC43, or 229E. To confirm the rapid test result, follow-up tests with molecular diagnostics and/or CT should be considered. This rapid test is not intended for home use. This rapid test is not intended for screening donated blood. Do not use highly hemolytic 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 expiry date. Use only human whole blood (collected from a vein or fingertip), serum, or plasma as a sample. Follow the package insert for accurate results. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from blood-borne pathogens even after cleaning and disinfection. Use appropriate precautions and follow all applicable regulations when disposing of used test kits.

Storage
Store the kit in a cool, dry place at a temperature between 2°C and 30°C. Keep away from direct sunlight. Exposure to a temperature and/or humidity different from those specified may lead to erroneous results. Do not freeze or refrigerate. Use the kit at a temperature between 15° and 30°C. Use the kit at a humidity between 10% and 90%. Do not use kits beyond the expiry date (printed on the test foil pouch and on the box).
Shelf life in intact packaging: 24 months.

Format
Each kit contains: the device, the buffer, the pipette (optional), and the package insert.

Code. 5555057