One step test for CK-MB/cTnI/Myo - CK-MB/cTnI/Myo card

Intended Use:

One Step Test for CK-MB/cTnI/Myo (Colloidal Gold) applies colloidal gold immunochromatography to detect CK-MB/cTnI/Myo in serum and plasma samples semi-quantitatively or quantitatively.



The Test Strips contain:

Sample pad, colloidal gold pad (sprayed by colloidal gold-labelled CK-MB/cTnI/Myo monoclonal antibody), chromatography membrane (T-line coated with CK-MB/cTnI/Myo monoclonal antibody, C-line coated with IgG), absorbent paper and lining.

Kit contains:

1. Foil bag contains one test card, one pipette and one desiccant 10 or 25

2. Manual 1

3. Standard Colorimetric Card 1

Matching Equipment: FIA8000 Series Quantitative Immunoassay Analyzer



Storage Requirements:

1. Store the strip at 4~30oC within 12 months.

2. Use the test card within 1 hour once the foil bag is opened.



Sample Material and Volume:

Serum/plasma 120 μl



Specimen Collection and Preparation:

1. A serum or plasma specimen is required for testing by this product.

2. The plasma specimen is suggested to use heparin as anticoagulant.

3. Transport specimens at room temperature or chilledly and avoid extreme temperatures.

4. It is recommended to avoid using severely hemolyzed specimens whenever possible, if a specimen appears to be severely hemolyzed, another specimen should be obtained and tested.

5. Test blood specimens on the strips immediately or within 2 hours after collected, if testing can’t be completed within 2 hours, the blood specimens must be stored at 4oC and used within 1 day. The serum or plasma specimen can be stored at -20oC (half a year at most) until testing.

6. The blood specimens must be restored to room temperature before testing.



Test Procedure:


1. Restore the test card and the blood specimen to room temperature (20~25oC better).

2. Open the pouch and label the strip with the patient specimen number.

3. Use the pipette to transfer blood from a sample collection tube.

4. Release the bulb slowly, dropping 3 to 4 drops (or 120 μl) of the sample.

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.