Instruction for use, pipette, buffer
Principle of Test:
INTENDED USE: One Step Cardiac Troponin I Test Device is intended for the qualitative determination of cardiac troponin I in plasma or serum. Measurement of troponin I values is useful in the evaluation of acute myocardial infarction (AMI).
1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. For Serum or Plasma specimens: Transfer 2 drops of serum or plasma (approximately 50 µL) to the sample well (S) , and start the timer.
4. Read results between 15-20 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
Positive: Two distinct colored lines appear, one in the control region (C) and another one in the test region(T). This indicates a positive test result and cardiac troponin I having been detected.
NOTE: The intensity of the colored line in the test region (T) is subject to variability reflecting the concentration of cTnI present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
Negative: Only one colored line appears in the control region (C). This indicates a negative test result and no cardiac troponin I having been detected.
Invalid: If the control line (C) fails to appear, the test results are invalid regardless of the presence or absence of the test line.
NOTE: 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 device. If problem persists, please contact your local distributor.