MYO,CK-MB and cTnI triple card Assay Kit POCT analzyer by Immunofluorescence Method
Inspection principle
This reagent forms a double antibody sandwich complex with myoglobin, creatine kinase
isoenzyme, and troponin I, and is detected by a fluorescence detector, so as to achieve the same
level of myoglobin and creatine kinase in serum, plasma, and whole blood. Quantitative
determination of the concentration of troponin I. After the sample to be tested and the buffer
are evenly mixed, they are added dropwise to the sample well of the test card. The sample reacts
with the fluorescently labeled antibody coated on the sample pad to form an antigen-antibody
complex, which is chromatographed on the nitrocellulose membrane, and The mouse
anti-human myoglobin monoclonal antibody, mouse anti-human creatine kinase isoenzyme
monoclonal antibody, and mouse anti-human troponin I monoclonal antibody produced specific
immune reactions and were captured. The amount of fluorescent complex captured is positively
correlated with the concentration of myoglobin, creatine kinase isoenzyme, and troponin I in the
sample. The fluorescence intensity is detected and converted into muscle according to the
calibration curve calibrated on the ID chip or test card. Concentrations of red protein, creatine
kinase isoenzyme, and troponin I.
Reagents components
The kit consists of a test card, buffer, and ID chip (optional). among them:
1.Test card: Consists of a reagent strip and a plastic box. The main components of the reagent
strip are: nitrocellulose membrane, absorbent paper, PVC board and labeling pad; the reagent
strip is coated with mouse anti-human MYO monoclonal antibody (each reagent strip contains
0.20μg～1.20μg), Mouse anti-human CK-MB monoclonal antibody (containing 0.08μg～0.80μg
on the reagent strip per person), mouse anti-human cTnI monoclonal antibody (containing
0.08μg～0.80μg on the reagent strip per person) and anti-rabbit IgG ( Each reagent strip contains
0.20μg～1.50μg), fluorescently labeled mouse anti-human MYO monoclonal antibody (each
reagent strip contains 0.06μg～0.22μg), mouse anti-human CK-MB monoclonal antibody (each
person Each kit contains 0.06μg～0.22μg), mouse anti-human cTnI monoclonal antibody (each
kit contains 0.06μg～0.34μg), fluorescently labeled rabbit IgG (each kit contains 0.20μg～1.50
μg).
2.Buffer: Tris buffer (Tris) (50mmol/L).
3.ID chip: Contains basic project information, batch information and calibration curve.
Applicable to IFP-2000,IFP-3000 produced by Xincheng Bio and AFS-1000, AFS2000A models
produced by Labsim. It is equipped with ID chip ; the ID chip stores basic project information,
batch information and calibration curve, and the barcode on the test card only contains batch
information. Applicable to Xincheng Bio's Auto-HFIAS 1000 and HFD-Station models without ID
chip . The basic project information, batch information and calibration curve are marked on the
test card in the form of a QR code.
The measurement system can be traced to the MYO,CK-MB and cTnI measurement system
approved by NMPA.
The components in the kits with different batch numbers cannot be interchanged or mixed.
Storage and stability
The test card and buffer solution were stored at 2℃~30℃ for 24 months, and the buffer solution
could be kept stable for 2h after being opened at 2℃~30℃.The test card foil bag should be used
within 2h after opening.Transportation and storage should be carried out under the condition of
2℃~30℃.
Applicable instrument
The models produced by Sichuan Xicheng Biological Co., LTD:
IFP-2000,IFP-3000,Auto- HFIAS 1000, HFD-Station dry fluorescence immunoassay analyzer,
The models produced by Guangzhou Labsim Biotechnology Co., Ltd.:
AFS-1000, AFS2000A dry fluorescence immunoassay analyzer.
| Category |
Test |
Linear range |
Time |
| Cardiovascular |
*CK-MB+Myo |
1.00~100.00ng/mL10.0~400.0ng/mL |
4/8min |
