Diagnostic Kit for Cardiac Troponin I Myoglobin and Isoenzyme MB of Creatine Kinase
Diagnostic Kit for Cardiac Troponin I ∕Isoenzyme MB of Creatine Kinase ∕Myoglobin
Methodology:Fluorescence Immunochromatographic Assay
Production information
| Model Number | cTnI/CK-MB/MYO | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit for Cardiac Troponin I ∕Isoenzyme MB of Creatine Kinase ∕Myoglobin | Instrument classification | Class II |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Fluorescence Immunochromatographic Assay | OEM/ODM service | Avaliable |
INTENDED USE
This kit is applicable to in vitro quantitative detection of concentrations of myocardial injury markers of cardiac
troponin I, isoenzyme MB of creatine kinasein and myoglobin in human serum/plasma/whole blood sample, and
it’s suitable for auxiliary diagnosis of myocardial infarction. This kit only provides test results of cardiac troponin I,
isoenzyme MB of creatine kinasein and myoglobin, and results obtained shall be used in combination with other
clinical information for analysis. It must only be used by healthcare professionals.
Test procedure
| 1 | Before using the reagent,read the package insert carefully and familiarize yourself with the operating procedures. |
| 2 | Select standard test mode of WIZ-A101 portable immune analyzer |
| 3 | Open the aluminum foil bag package of reagent and take out the test device. |
| 4 | Horizontally insert the test device into the slot of immune analyzer. |
| 5 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface. |
| 6 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type. Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step. |
| 7 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label. |
| 8 | Take out sample diluent upon consistent information, add 80μL serum/plasma/whole blood sample, and thoroughly mix them; |
| 9 | Add 80µL aforesaid thoroughly mixed solution into well of test device; |
| 10 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 11 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 12 | After test by immune analyzer is completed, test result will be displayed on test interface or can be viewedthrough “History” on home page of operation interface. |
Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.
Superiority
Testing time:10-15mins
Storage:2-30℃/36-86℉
Methodology:Fluorescence Immunochromatographic Assay
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• 3 tests in one time, saving times.
• High Accuracy
The Clinical Performance
Clinical performance of this product’s assessed through collection of 150 cases of clinical samples.
a) In case of cTnI item, corresponding marketed kit of chemiluminescence assay’s used as reference reagent,
detection results have been compared and their comparability has been studied through linear regression, and
correlation coefficients of the two assays are Y=0.975X+0.074 and R=0.9854 respectively;
b) In case of CK-MB item, corresponding marketed kit of electrochemiluminescence assays used as reference
reagent, detection results have been compared and their comparability has been studied through linear
regression, and correlation coefficients of the two assays are Y=0.915X+0.242 and R=0.9885 respectively.
c) In case of MYO item, corresponding marketed kit of time-resolved fluor immunoassays used as reference
reagent, detection results have been compared and their comparability has been studied through linear
regression, and correlation coefficients of the two assays are y=0.989x+2.759 and R=0.9897 respectively.
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