One step Troponin I/CK-MB/Myoglobin test is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I, CK-MB and Myoglobin in whole blood, serum or plasma as an aid in the diagnosis, prognosis and evaluation of patients with suspected myocardial damage such as Acute Myocardial Infarction (AMI), Unstable Angina (UA), Acute Myocarditis and Acute Coronary Syndrome (ACS).
TEST PROCEDURE:
1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the test device on a flat, dry surface.
For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μl) to the sample well (S) of the test cassette, and start the timer.
For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) to the sample well (S) of the test device, then add 1 drop of buffer and start the timer.
For Finger stick Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) or allow 2 hanging drops of finger stick whole blood specimen (approximately 50μl) to the sample 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 between 10-20 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS:2. Place the test device on a flat, dry surface.
For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μl) to the sample well (S) of the test cassette, and start the timer.
For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) to the sample well (S) of the test device, then add 1 drop of buffer and start the timer.
For Finger stick Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) or allow 2 hanging drops of finger stick whole blood specimen (approximately 50μl) to the sample 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 between 10-20 minutes. Do not interpret results after 20 minutes.
Positive:Two distinct colored lines appear. One vivid colored line is visible in the control region (C),and another apparent colored line appears in the test region(T).
Negative:One colored line appears in the control region (C). No line is visible in the test region (T).
Invalid:Control line (C) fails to appear, whether there is a visible line in test region (T).
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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
SPECIFICATION:
Description | Specimen | Format | Catalog No. | Sensitivity | Package Size | Strip Width | Certificate |
Cardiac Marker Test Panel (cTnI/CK-MB/MYO) | Serum/Plasma | Multi-Panel | F40-40 | MYO:80ng/mL CK-MB:5ng/mL cTnI:1ng/mL |
15 Tests | 4.0 mm | CE |
Whole Blood | F40-41 |