CHECK TEST
Covid-19 RBD Test

Description
A rapid immunochromatographic test for the qualitative detection of IgG antibodies to the SARS-CoV-2 spike (S) protein receptor-binding domain (RBD) in human fingerstick whole blood approximately 10 days after vaccination. It is designed to aid in the identification of individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 IgG S-RBD antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.

How to use
Before the test:
Bring the test and buffer to room temperature (15-30°C) before use.
Wash your hands thoroughly with warm water and dry them.
Remove the test cassette from the sealed pouch and use it within 1 hour.
Do not touch the test area (the strip next to the letters C, T, and S) of the test strip. Best results are obtained if the test is performed immediately after opening. Place the test on a flat, clean surface.
1. Use the alcohol swab to clean the tip of your middle or ring finger where you want to prick your finger. Let it dry for 10 seconds.
2. Gently twist and remove the lancet cap. Open the lancet only just before testing.
3. Press the sterile lancet firmly against the tip of your middle or ring finger.
4. To increase blood flow, use your thumb and forefinger to apply gentle pressure around the puncture site.
5. Without squeezing the dropper, apply it to the blood. The blood should reach the line indicated on the dropper. You can massage your finger again to obtain more blood if the line is not reached. Avoid air bubbles; if air bubbles appear, discard the blood in a plastic bag (e.g., a biosafety bag), then repeat the previous collection steps.
6. Place the tip of the dropper in contact with the center of the sample well(s) and release all the blood immediately after collection.
7. Add 2 drops of buffer to the sample well (S) and start the timer. Do not move the test during development.
8. Read the results after 10 minutes. Do not interpret results after 20 minutes.
Positive: *Two colored lines appear. One colored line in the control region (C) and another in the test region (T). A positive result in the test region indicates the detection of SARS-CoV-2 S-RBD IgG in the specimen.
*Note: The intensity of the color in the test line (T) varies depending on the amount of S-RBD SARS-CoV-2 IgG present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
Negative: A colored line appears in the control region (C). No colored line appears in the test region (T). A negative result indicates that the SARS-CoV-2 IgG S-RBD antibody was not detected in the specimen.
Invalid: The control line does not appear. Insufficient sample volume or improper procedural techniques are the most common reasons for the control line not appearing. Review the procedure and repeat the test with a new device. If the problem persists, discontinue use of the test immediately and contact your supplier.

Warnings
1. This package insert must be read in its entirety before performing the test. Failure to follow the instructions in the package insert may result in inaccurate test results.
2. For in vitro self-test diagnostic use only.
3. Keep out of reach of children. Testing on children and young people should be performed by an adult.
4. Do not eat, drink, or smoke in the specimen or kit handling area.
5. Do not use if the test package is damaged.
6. Wash your hands thoroughly before performing the test.
7. Make sure you use an adequate amount of sample during the test. Too little or too much sample may cause inconsistent results.
8. Do not touch the test reaction area on the device strip.
9. The used test must be disposed of according to local regulations. Do not reuse any component of the kit.
10. Do not drink the buffer contained in the kit. Handle the buffer carefully to avoid contact with skin or eyes; if this occurs, rinse immediately with running water.
11. The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) should only be used on individuals vaccinated against COVID-19.
Do not use the kit beyond the expiration date printed on the sealed package. Do not open the sealed package until you are ready to perform the test.

Conservation
Store in the sealed container at room temperature or refrigerated (2-30°C). Do not freeze.

Format
Package containing:
- test cassette (each cassette is in a sealed package with desiccant);
- package leaflet;
- buffer;
- alcohol swab;
- sterile lancet;
- dropper;
- biosafety bag.