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CK-MB Fluorescence Immunoassay Test For Quantitative Detection

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CK-MB Fluorescence Immunoassay Test For Quantitative Detection

Country/Region	china
City & Province	hangzhou zhejiang
Categories	Dyestuff Intermediates

Product Details

CK-MB Test Cassette Use By fluorescence Immunoassay Analyzer In Human whole blood /serum /plasma

The CK-MB Test Cassette is for the quantitative detection of human CK-MB in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).The test result is calculated by Fluorescence Immunoassay Analyzer.

Product Name:	CK-MB Test Cassette Use By Fluorescence Immunoassay Analyzer In Human Whole Blood /serum /plasma
Format:	Cassette
Certificate:	CE
Pack:	10T/25T
Shelf Life:	2 Years
Principle:	Fluorescence Immunoassay
Specimen:	WB/S/P
Reading Time:	15 Minutes
Storage Temperature:	4-30℃
Cut-Off:	5 Ng/mL

PRODUCT FEATURES

【PERFORMANCE CHARACTERISTICS】

1. Accuracy

The test deviation ≤±15%

2. Sensitivity

The CK-MB Test Cassette can detect levels of Creatine Kinase MB as low as 0.2ng/mL whole blood, serum or plasma.

3. Detection range

0. 2~75ng/mL

4. Linear range

0. 2~75ng/mL, R≥0.990

5. Precision

C.V. ≤15%

Fast Result (15 minutes)

Simple Operation (Less Training Required)

Objective (Results Read by Analyzer)

Stringent Quality Control Insure High Accuracy

User-friendly (Simple Plug & Play Operation)

High Efficiency (Both STAT Testing and Batch Testing)

A rapid test for measuring Creatine Kinase MB (CK-MB) in whole blood /serum /plasma with the use of Fiatest ^TM fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.

Application And Description:

Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa.1Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue. 2.The release of CK-MB into the blood following MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours. 3. CK-MB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of MI.

The CK-MB Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagents to quantitatively detect CK-MB in whole blood, serum or plasma.

How to use?

Refer to Fiatest ^TM Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be conducted in room temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test” mode.

2. Remove the ID card and insert it into the Analyzer port.

3. Serum/plasma: Pipette 75μL serum/plasma into the buffer tube; mix the specimen and the buffer well.

4. Whole blood: Transfer 100μL whole blood into the buffer tube with pipette; mix the specimen and the buffer well.

5. Add diluted specimen with a Pipette: Pipette 75μL diluted specimen into the sample well. Start the timer at the same time.

6. There are two test modes for Fiatest ^TM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Fiatest ^TM Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after sample application and click "Test", the Analyzer will automatically give the test result after a few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample application, click "New test" at the same time, the Analyzer will automatically counting down 15 minutes. After the countdown, the Analyzer will give the result at once.

INTERPRETATION OF RESULTS
Results read by Fiatest ^TM Fluorescence Immunoassay Analyzer.
The result of tests for HbA1c is calculated by Fiatest ^TM Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of Fiatest ^TM Fluorescence Immunoassay Analyze.
Linearity range of Fiatest ^TM HbA1c Test is 0.2-75 ng/L.