Product IVD (In Vitro Diagnosis)

D-dimer rapid test kit

D-dimer rapid test kit (Dry immune fluorescence quantitative method)

                                   Instruction

1.Product name

D-dimerRapidTest Kit

2. Specifications

25 tests/kit

3. Usage

This test kit is used to detect D-dimer concentration in whole blood、Serum or Plasma quantitatively.

4. Clinical significance

D - dimer is in the blood coagulation - fibrinolysis system, due to the effect of coagulation factor 13, a product derived from cross-linked fibrin acted on by plasmin, there is all kinds of molecules class D - dimer in blood such as YY/DXD、YD/DY、DD/E、DD complex etc.

 The increase of D-dimer in blood show that there is thrombosis , fibrinolytic system startup. Diseases like malignant tumor, obstetric disease, vascular lesions and DIC (disseminated intravascular coagulation syndrome) etc. D - dimer show highconcentration.

5. Principle

This test kit use double antibody sandwich method, to detect D-dimmer level in sample. The purified

D- dimmer coated on NC membrane. When testing, put sample into buffer and mix it evenly,there isfluorescein labeled D-dimmer antibody in buffer. If there is D-dimmer antibody in sample, it can combine with fluorescein labeled D-dimmer antibody in buffer, form a complex, affected by chromatography, it reacts with coated D-dimmer antibody when coming to the place which coated D-dimmer antibody. If no D-dimmer antibody in sample, then no reaction. When the reaction over, put the test card into Fluorescence Spectrometer, calculate the D-dimmer antibody concentration by the strength of the fluorescence signal.

6. Components

Code

Items

Quantity

1

IC card

1 piece/box

2

Rapid test cassette

25 pieces/box

3

Buffer

25 pieces/box

4

Instruction

1 piece/box

5

Qualifier

1 piece/box

Note: Shake the bottle to even before use, do not mix use the reagents from different lot no.

7. Storage and expiry date

1). Storage: Store at2~8℃ in dark.

2). Expiry date: 12 months, date of production is on box

8. Applicable Instrument

Fluorescence SpectrometerLP2100 manufactured by Shenzhen Lvshiyuan Biotechnology Co.,Ltd

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Company: Shenzhen Lvshiyuan Biotechnology Co.,Ltd

WeChat/WhatsApp: +86-13427908554

Mobile: +86-18165709090 Skype: bellazou3

E-mail: info@lsybt.com, lsy@lsybt.com

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