INTENDED USE:
The CK-MB test device is a rapid chromatographic immunoassay for the qualitative detection of CK-MB in human whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
TEST PROCEDURE:

1. Bring the pouched test device to room temperature (15-30°C) 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 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 15-20 minutes. Do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS：
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
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.

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
(CK-MB) Creatine Kinase-MB Test	Serum/Plasma	Cassette	F30-20	5ng/ml	25 Tests	4.0 mm	——
	Whole Blood		F30-21		25 Tests