SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood), For Self-testing
INTENDED USE
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
Fingerstick Whole Blood |
| Certificate |
CE1434 |
| Reading Time |
10 minutes |
| Pack |
1T,2T,5T,7T,10T,20T/25T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
97.50% |
| Specificity |
99.40% |
| Accuracy |
98.20% |
The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human Fingerstick Whole Blood approximately 10 days after vaccination.
It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the
detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.
MATERIALS PROVIDED
• Test Cassette(Each test cassette is sealed in foil pouch with a desiccant)
• Package insert
• Buffer
• Alcohol pad
• Sterile lancet
• Dropper
• Biosafety bag
(Optional)
MATERIALS REQUIRED BUT NOT PROVIDED
Timer
STORAGE
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). DO NOT FREEZE.
Do not use the kit after expiration date printed on the test pouch.
Do not open the foil pouch until you are ready to use the test.
Test cassette should be used within 1 hour after opening.
TESTING
Before testing:
Allow the test and buffer to room temperature (15-30°C) before testing.
Wash hands thoroughly in warm water and dry.
Take out the test cassette from the foil pouch and use it within 1 hour. Do not touch the test reaction area (strip area beside to C, T, S) of the test strip. Best results will be obtained if the assay is performed immediately after opening.
Place the test on a flat and clean surface.
1. Use alcohol pad to clean the fingertip of the middle finger or ring finger as the puncture site. Let it dry for 10 seconds.
2. Carefully rotate and pull off the lancet cap. Only open the lancet before testing.
3. Press the sterile lancet firmly against the fingertip of the middle finger or ring finger.
4. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
5. Without squeezing the dropper, put it in contact with the blood.
Draw the blood to the line indicated on the dropper.
You may massage again your finger to obtain more blood if the line is not reached.
Avoid air bubbles, discard the blood into a plastic bag (e.g., biosafety bag) if air bubbles happen, then repeat above
collecting steps.
6. Put the end of the dropper in contact with the center of thespecimen well(S) and release all the blood immediately after collection.
7. Add 2 drops of buffer to the Specimen well(S) and start the timer. Do not move the test during test developing.
8. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: After test is completed, thoroughly clean the surface of testing.
Do not reuse any used components of the kit.
Place all the used components of the test kit into the plastic bag (e.g., biosafety bag) and tightly seal it, then dispose according to local regulation.
QUESTIONS & ANSWERS
1. How can I know my test is working well?
If your test is working well, you will see a line in the control line area(C) on the test cassette. If there is no line in the control line
area, your test did not work and the test result is invalid.
2. When is the best time to run the test?
Test can be done at any time of the day.
3. How soon can I read my results?
You can read your results at 10 minutes after sample and buffer adding, do not read result after 20 minutes.
4. Can the result be wrong? Are there any factors that can affect the test result?
The results will only give accurate results as far as the fresh fingerstick whole blood used and followed the instructions carefully. Nevertheless, the result can be incorrect. Non-SARS-CoV-2 coronavirus strains or other interference factors may cause a preliminary Positive Result.
5. How to read the test if the color and the intensity of the lines are different?
The color and intensity of the lines have no importance for result interpretation. The test should be considered as Positive
whatever the color intensity of the test line (T) is.
6. What should I do if the test result is positive but I was not vaccinated?
If your test result is positive but you were not vaccinated, you should isolate yourself and contact with your local healthcare
provider to perform PCR test in case of COVID-19.
7. What should I do if the test result is negative but I was vaccinated?
If you were vaccinated and the test result is negative, it may because the antibody level is below the detection level or no
SARS-CoV-2 S-RBD IgG antibody detected; it is recommended to run a new test several days later. If the test result is still negative, contact with your healthcare provider.
