D-Dimer Fast Reading Test Use By cItest GO fluorescence Immunoassay Analyzer In Human whole blood /serum /plasma

Application:

The D-Dimer Test Cassette (Whole Blood/Plasma) is based on Fluorescence Immunoassay to measure D-Dimer in whole blood or plasma as an aid in the diagnosis of DVT and PE.

Description:

D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. Its formation or increase reflects the activation of coagulation and fibrinolysis system, and its plasma level can represent the production of thrombin active agent fibrin in vivo. It can be used as an indicator of thrombosis in the body. The D-dimer content in patients with thrombosis is significantly elevated.

In addition, studies have shown that low levels of D-Dimer (0.1-0.5mg/L) are closely related to the occurrence of cardiovascular diseases, and high levels of D-Dimer may be early exclusion diagnostic indicators for DVT and PE.

How to use?

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

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

2. Take out the ID card and insert it into the Analyzer port.

3. Plasma: Pipette 5 μL plasma into the buffer tube, mix the specimen and the buffer well.

4. Whole blood: Transfer 7.5 μL whole blood into the buffer tube with pipette; mix the specimen and the buffer well.

5. Add diluted specimen with a Pipette: Pipette 85 μL diluted specimen into the sample well of the test cassette. Start the timer at the same time.

6. There are two test modes for CitestTM GO Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode.

Please refer to the user manual of CitestTM GO Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately. The Analyzer will automatically give the test result after a few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after adding specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After the countdown, the Analyzer will give the result at once.

INTERPRETATION OF RESULTS

Results read by CitestTM GO Fluorescence Immunoassay Analyzer.

The result of tests for D-Dimer is calculated by CitestTM GO Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of CitestTM GO Fluorescence Immunoassay Analyze.
Linearity range of Citest TM D-Dimer Test is 0.1~10 mg/L.
Reference range:＜0.5 mg/L

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.