INTENDED USE:
One Step Troponin I Test Cassette is intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values is useful in the evaluation of acute myocardial infarction (AMI).
TEST PROCEDURE:
1. Bring the pouched test cassette to room temperature (15-30°C) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test cassette 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 50μl) to the sample well (S) , and start the timer.
4. For Whole Blood specimens: Transfer 2 drops of whole blood (approximately 50μl) to the sample well (S) . then add 1 drop of buffer and start the timer.
5. Read results between 10-20 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS：
Positive: Two distinct colored lines appear, one in the control region (C) and the other 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.

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
(cTnI) Troponin I Test	Serum/Plasma	Strip	F10-11	1ng/ml	50 Tests	3.0 mm	CE
		Cassette	F10-20		25 Tests	4.0 mm
	Whole Blood		F10-21		25 Tests	4.0 mm