Medical Diagnostic Kit

Detailed Product Description (take Troponin I for example)

cTnI fast test kit applies colloidal gold immunochromatography to detect cTnI in serum and plasma sample semi-quantitatively.
 

Intended Use: 

Cardiac Troponin I Fast Test Kit  applies colloidal gold immunochromatography to detect cardiac Troponin I 

(cTnI) in serum and plasma samples  semi-quantitatively or quantitatively. This test is used  as an aid in the

diagnosis of Myocardial Infarction such  as Acute Myocardial Infarction, Unstable Angina, Acute  Myocarditis, 

and Acute Coronary Syndrome. 

Principle of the Procedure:

The test kit contains two high specific and sensitive anti-human cardiac Troponin I monoclonal antibodies:

one gold-labelled and coated on the polyester film, the other biotinylated and fixed on the test line of the

 product. The antibodies form sandwich complexes with any cTnI that is present in the blood sample. The 

sample passes through the detection zone, in which the cTnI sandwich complexes gather along a line,  

appearing as a purplish red streak (the test or signal line). Excess gold-labelled antibodies gather along 

the control line, signalling visually that the test is valid. The intensity of the test line increases in proportion 

to the cardiac Troponin I concentration.

Test Procedure:

1. Please read the manual carefully before testing, restore the samples and the test card to room temperature

and number the samples.

2. Remove the test card from bag, and use it within 1 hour. (The test card should be used as quickly as

possible once the bag is opened, especially if the room temperature is over 30 °C and the humidity is over 60%).

3. Put the test card on a clean table, horizontally layed and tagged.

4. Vertically dropping 120 μl or 3 to 4 drops of samples to the sample port on the test card.

5. Referring to the standard colorimetric card, get the semi-quantitative result by eye, or read the quantitative

result with the matching equipment. The result must be read within 10~30 mins.

Warnings and Precautions: 

1. Pipettes can be used for one specimen only in order to avoid cross-contamination. 

2. The best testing temperature is 15~30 C, and the best humidity is 40~60%. 

3. Patient samples, used test card and transfer pipettes may be potentially infectious. Proper handling and 

disposal methods should be established by the laboratory direction in accordance with local regulations.