Description
VivaDiag COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic test for the qualitative detection of lgM and lgG antibodies to COVID-19 in human whole blood (collected from a vein or fingertip), serum or plasma. The kit includes the test device and buffer. It is intended for in vitro diagnostic use only and can be used in point-of-care testing (POCT) and in centralized laboratories.
The test is based on immunoassay technology. The device contains: 1) Conjugate pad: recombinant SARS-CoV-2 antigen conjugated with colloidal gold and a control antibody labeled with gold. 2) Nitrocellulose membrane: equipped with two detection bands (lgG band and lgM band) and a quality control band (C band). The lgM band, coated with anti-human rat lgM monoclonal antibodies, detects anti-COVID-19 lgM antibodies. The lgG band, coated with anti-human rat lgG monoclonal antibodies, detects anti-COVID-19 lgG antibodies. The C band is coated with quality control antibodies.
When the blood/serum/plasma sample is introduced into the well of the device, the sample will begin to flow forward along the device. If the sample introduced contains lgM antibodies, the antibodies will bind to the colloidal gold-labeled viral antigen, then form a sandwich complex with the anti-human IgM monoclonal antibody coated on the IgM band, the lgM band will appear reddish-purple, indicating that the COVID-19 lgM antibody is positive.
If the sample contains lgG antibodies, the antibodies will bind to the colloidal gold-labeled viral antigen, then form a sandwich complex with the anti-human IgG monoclonal antibody coated on the IgG band, the lgG band will appear reddish-purple, indicating that the COVID-19 lgG antibody is positive.
If both IgG or IgM bands do not color, the test result will be negative. The test also contains the C band for quality control: for the test to be valid, the C quality control band must appear anyway, whether one or both of the other two bands appear or not at all.

Instructions for use
Test procedure:
1) extract the test kit and leave it for at least 30 minutes in the room where the test will be carried out;
2) place the test equipment on a clean and dust-free surface;
3) first insert 10?L of whole blood or serum or plasma into the blood area (in the well) on the test, then apply two drops (about 60-80?L) of buffer into the well;
4) read the result after 15 minutes.
Interpretation of results:
1. Anti-COVID-19 lgM antibody is detected if: the C quality control band and the lgM band have both colored and the lgG band does not color. This means that the anti-COVID-19 lgM antibody is positive.
2. Anti-COVID-19 lgG antibody is detected if: the C quality control band and the lgG band have both colored and the lgM band does not color. This means that the COVID-19 lgG antibody is positive.
3. Anti-COVID-19 lgG and lgM antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that both anti-COVID-19 lgG and lgM antibodies are positive.
- Negative result: anti-COVID-19 lgG and lgM antibodies are not detected if only the C quality control band colors but the lgG and lgM bands do not color, this means that the test is negative.
- Invalid result: if the C quality control band does not color, regardless of whether the lgG and lgM bands color or not, the result is invalid and the test must be started again.

Warnings
For in vitro diagnostic use. Avoid contact with eyes and skin. In case of reagent leakage, wash thoroughly with water before disposal. If blood collected from the fingertip is applied with a pipette, the rest of the blood on the fingertip should be cleaned with an alcohol swab.
Limitations of use:
-The test result cannot be used for the diagnosis of COVID-19. The test is to be considered an aid in the diagnosis of COVID-19 virus infection. Any sample that tests positive for COVID-19 must be confirmed by other analytical methods. If the result does not correspond to the clinical evaluation, please perform more tests.
-Do not use highly hemolytic samples.
-Do not reuse the same test multiple times.
-The test can only be performed with whole blood (collected from a vein or fingertip) or serum or plasma. If another type of fluid/sample is used, inaccurate results may be obtained.
-Read the test result at the fifteenth minute after buffer application, before or after inaccurate results may be read.
-Strictly adhere to the package insert during testing.
Materials needed but not supplied: sterile needles (for fingertip collection), alcohol swab, clock/timer.

Storage
Store the kit in a cool and dry place at a temperature between 2-30°C (36-86°F). Keep away from light. Exposure or storage of the kit at temperatures different from those specified and/or humidity may lead to incorrect results.
Do not freeze, deep freeze or refrigerate.
Use the kits at a temperature between 18-25° C.
Use the kits at a humidity between 10-90%.
Do not use the kits beyond the expiry date (printed on the aluminum pouch and on the box label).
Attention: if not used in the short term, we recommend storing the kit at a temperature between 2-8° C.
All expiry dates are written in yyyy-mm year-month format, e.g. 2021-06 means June 2021.
Validity with intact packaging: 12 months.

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