DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Take out the test from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a flat and clean surface. For Venous Whole Blood Specimen, Serum or Plasma Specimen
For Serum or Plasma specimen:
• Use a dropper: Hold the dropper vertically, draw the Serum or Plasma to the fill line (approximately 10μL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80μL) , and start the timer.
• Use a pipette: Transfer 10μL of Serum or Plasma to the specimen well(S), then add 2 drops of buffer (approximately 80μL) and start the timer.
For Venous Whole blood specimen:
• Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approximately 20μL) of Whole blood to the sample well(S). Then add 2 drops of buffer (approximately 80μL) and start the timer.
• Use a pipette: Transfer 20μL of Whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80μL) , and start the timer.
Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
For Fingerstick Whole Blood
1. Use alcohol pad to clean the fingertip of the middle finger or ring finger as the puncture site.
2. Carefully rotate and pull off the lancet cap.
3. Push the sterile lancet firmly into the fingertip of the middle finger or ring finger.
4. Wipe off the first drop of blood. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
5. Hold the dropper vertically, draw the blood to 1cm above the fill line and transfer 1 full drop of blood (approximately 20L) to the specimen well(S), then add 2 drops of buffer (approximately 80 L) , and start the timer.
6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
Positive result in the test region indicates there is SARS-CoV-2 S-RBD IgG in the sample.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 S-RBD IgG present in the sample. So any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
