Immunofluorescence Assay CK-MB/cTnI/Myo Combo Fast Test Kit

Short Description:

Diagnostic Kit for Isoenzyme MB of Creatine Kinase

Methodology: Fluorescence Immunochromatographic Assay

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

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Product Detail

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1. INTEDED 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.

2. PRODUCT SPECIFICATION

Model No.	CK-MB/CTNI/MYO
Methodology	Fluorescence Immunochromatographic Assay
Sample Type	serum/Plasma/Whole Blood
Time to Result	10-15mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485,CE,MHRA

MAIN KIT COMPONENTS

* Test device

* Sample diluents

* Instructions for Use

PACKING

* 25 test /kit

* Aluminum foil bag labeling

* shrink wrap

3.TEST METHOD

4.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.