A rapid test for measuring D-Dimer in whole blood or plasma with the use of FluroLit^TMGO fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.

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 FluroLit^TMGOFluorescence 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 FluroLit^TMGOFluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of FluroLit^TMGOFluorescence 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 FluroLit^TMGO Fluorescence Immunoassay Analyzer.
The result of tests for D-Dimer is calculated byFluroLit^TMGO Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of FluroLit^TMGO Fluorescence Immunoassay Analyze.
Linearity range of FluroLit TM D-Dimer Test is 0.1~10 mg/L.
Reference range:＜0.5 mg/L

Catalogue Number	Item Name	Sample	Test Range	KIT size
FI-DDM-402	D-Dimer Test Cassette	WB/S/P	0.1~10 mg/L	10T/25T

Tag:

Place of Origin:	China
Brand Name:	Fiatest Go
Certification:	CE, ISO13485
Model Number:	FI-DDM-402

Minimum Order Quantity:	N/A
Price:	negotiation
Packaging Details:	10T/25T
Delivery Time:	2-4 Weeks
Payment Terms:	Ex works
Supply Ability:	10 M tests/month

Format:	Cassette	Specimens:	Whole Blood /serum /plasma
Kit Size:	10T/25T	Certificate:	CE,ISO 13485
Storage:	2-30℃	Test Range:	0.1~10 Mg/L
High Light:	One Step Rapid Test , home testing kits

	Hangzhou AllTest Biotech CO.,LTD
	#383, Qiaoxin Road, Xiasha Street, Qiantang Disctrict, Hangzhou, Zhejiang, P.R.China
	86-571-56267891
	selina.wu@alltests.com.cn

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

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