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DIRECTIONS FOR USE

Allow test device, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface.
For Whole Blood, Serum or Plasma specimens:
Hold the dropper vertically and transfer 2 drops of specimen (or approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.
For Fingerstick Whole Blood specimens:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 µL (or 2 drops) of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE RESULT:
A colored band appears in the control band region (C) and another colored band appears in the T band region.
NEGATIVE RESULT:
One colored band appears in the control band region (C). No band appears in the test band region (T).
INVALID RESULT:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of cTnI present in the specimen. Therefore, any shade of color in the test line region
(T) should be considered positive.