One Step Rapid Medical Test Kits Troponin I cTnl Diagnostic Test Device Cassette

For in vitro diagnostic use only 

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Cardiac Troponin I(fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Cardiac Troponin I (cTnI) in human serum or plasma, it is used for auxiliary diagnosis of AMI(Acute MyocardialInfarction). All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

cTnI levels increased several hours after Myocardial infarction occurred, peaked at 12-16 hours, and remained elevated 4-9 days after Myocardial infarction occurred. The global definition of the third myocardial infarction in 2012: The preferred biomarker-cTn(I or T), has high myocardial tissue specificity and high clinical sensitivity. Changes in the concentration of cTn are essential to the diagnosis of AMI

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with anti cTnI antibody on the test region and goat anti-rabbit IgG antibody on the control region. Lable pad is coated by fluorescence-labeled anti cTnI antibody and rabbit IgG in advance. When testing a positive sample, the cTnI antigen in sample combines with fluorescence-labeled anti cTnI antibody, and form an immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti cTnI coating antibody, forms a new complex. cTnI level is positively correlated with fluorescence signal, and the concentration of cTnI in the sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components:

Test card individually foil pouched with a desiccant25T

Sample diluents25T

Package insert1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container, timer

SAMPLE COLLECTION AND STORAGE

1. The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma.

2. According to standard techniques collect the sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. 

3. All sample avoid freeze-thaw cycles.

ASSAY PROCEDURE

Please read the instrument operation manual and package insert before testing.

 1. Lay aside all reagents and samples to room temperature.

2. Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.

3. Scan the identification code to confirm the test item.

4. Take out the test card from the foil bag.

5. Insert the test card into the card slot, scan the QR code, and determine the test item.

6. Add40μL serum or plasma sample to sample diluent, and mix well.

7. Add 80μL sample solution to sample well of the card.

8. Click the"standard test"button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.

9. Refer to the instruction of Portable Immune Analyzer(WIZ-A101).