Multi-panel

 

 

  Product Name:
  Cardiac Marker Test Panel
  Accessories:
  Instruction for use, pipette, buffer, sterile lancet
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: Myoglobin:80ng/mL , CK-MB:5ng/mL, Troponin I: 1ng/mL . 



INTENDED USE: Cardiac Marker Test Panel 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 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.For Whole Blood Specimens: Transfer 1 drop of whole blood (approximately 25µL) 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 distinct colored lines appear, one in the control region (C) and another apparent colored line in the test region(T). This indicates a positive result no matter the test line is darker or weaker than the control line and cardiac Troponin I, CK-MB or Myoglobin having been detected.
Negative: Only one colored line appears in the control region (C). No line is visible in the test region (T). This indicates a negative test result and no cardiac Troponin I, CK-MB or Myoglobin having been detected.     Invalid: If control line 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 the problem persists, contact your local distributor.