Jp.
TEST PROCEDURE
1. Allow the test, specimen, and buffer to reach room temperature (15-30°C) prior to testing. Remove the test cassette from the sealed pouch and use it within 1 hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For
Serum or Plasma specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10μl), and transfer the specimen to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80μl) and start the timer. Avoid trapping air bubbles in the sample well. See illustration below.
For
Whole Blood (Venipuncture) specimens:
Hold the dropper vertically and transfer 1 drop of whole blood (approximately 20μl) to the specimen well, then add 2 drops of buffer (approximately 80μl) and start the timer. See illustration below.
For
Whole Blood (Fingerstick) specimens:
To use a capillary tube: Fill the capillary tube and transfer approximately 20μl of fingerstick whole blood specimen to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80 μl) and start the timer. See illustration below.
3. Wait for the coloured line(s) to appear. Read the results at
10 min, do not interpret the results after 20 min.
INTERPRETATION OF RESULTS
IgG POSITIVE:*Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific-IgG antibodies.
IgM POSITIVE:*Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific-IgM antibodies.
IgG and IgM POSITIVE:*Three lines appear. One coloured line should be in the control line region (C), and two coloured lines should appear in IgG test line region and IgM test line region.
*NOTE: The intensity of the colour in the test line regions will vary depending on the titre of SARS-CoV-2 antibodies present in the specimen. Therefore, any shade of colour in the test line region should be considered positive.
NEGATIVE: One coloured line appears in the control region (C). No apparent coloured line appears in the IgG or IgM test region (T).
INVALID: Control line fails to appear. Insufficient sample 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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