Screen check test - sars cov2 srbd

Product Description

This product is a rapid immunochromatographic test for the qualitative detection of Igg S-Rbd antibodies to Sars-Cov-2 in human fingerprick whole blood, useful for identifying the adaptive immune response approximately 10 days after vaccination.

Indications

Rapid immunochromatographic test for the qualitative detection of Igg antibodies to the spike (S) protein receptor binding domain (Rbd) of Sars-Cov-2 in human fingerprick whole blood approximately 10 days after vaccination. Designed to assist in the identification of individuals with an adaptive immune response to SARS-2. Results are for the detection of S-RBD IgG antibodies to SARS-2. Positive results indicate the presence of S-RBD IgG antibodies to SARS-2.

Method Instructions for Use and Dosage

Before testing:

• Bring the test and the 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 reaction area (the strip next to the letters C, T, S) of the test strip. Best results are obtained if the test is performed immediately after opening. Place the test on a clean, flat surface.

1. Use the alcohol swab to clean the tip of your middle or ring finger where you will 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, place it in contact with 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; discard the blood in a plastic bag (e.g., biosafety bag) if air bubbles occur, then repeat the previous collection steps.
6. Place the tip of the dropper in the blood vessel. Place the dropper tip 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 results at 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 Igg S-Rbd Sarscov-2 in the sample.

*Note: The intensity of the buffer varies depending on the sample. The color of the test line (T) varies depending on the amount of Igg S-Rbd Sars-Cov-2 present in the sample. 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 Igg S-Rbd Sars-Cov-2 antibody was not detected in the sample.

Invalid: The Control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most common reasons for the failure of the control line to appear. 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

• 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.
• For in vitro self-test diagnostic use only.
• Keep out of reach of children. Testing of children and young people should be performed by an adult.
• Do not eat, drink, or smoke in the area where specimens or kits are handled.
• Do not use if the test package is damaged.
• Wash your hands thoroughly before performing the test.
• Make sure you have used an adequate amount of specimen when testing. Too little or too much specimen may cause incorrect results.
• Do not touch the test reaction area on the device strip.
• The used test must be disposed of according to local regulations. Do not reuse any component of the kit.
• 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.
• The Sars-Cov-2 Igg S-Rbd Antibody rapid test (fingerstick whole blood) must be used only on subjects 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 have received the kit. ready to perform the test.

Storage

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

Format

Package containing:

• Test cassette (each cassette is in a sealed pouch with desiccant);
• Instructions for Use;
• Buffer;
• Alcohol swab;
• Sterile lancet;
• Dropper;
• Biological safety bag.