Renewable Design for CE approved monkeypox test - Diagnostic Kit for Cardiac Troponin I Myoglobin and Isoenzyme MB of Creatine Kinase – Baysen factory and manufacturers

Renewable Design for CE approved monkeypox test - Diagnostic Kit for Cardiac Troponin I Myoglobin and Isoenzyme MB of Creatine Kinase – Baysen

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Renewable Design for CE approved monkeypox test - Diagnostic Kit for Cardiac Troponin I Myoglobin and Isoenzyme MB of Creatine Kinase – Baysen Detail:

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.

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