D-Dimer Rapid Test (1 pc/box)

D-Dimer Rapid Test

The D-Dimer Rapid Test Kit is a qualitative immunochromatographic assay for the detection of D-Dimer in human whole blood or plasma. This test serves as an aid in the evaluation and diagnosis of patients suspected of disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE). Elevated D-Dimer levels generally indicate activation of the coagulation process and can assist physicians in clinical decision-making.

Clinical Applications

• Venous Thrombosis and Embolism: Elevated D-Dimer levels are often associated with venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

• Disseminated Intravascular Coagulation (DIC): DIC is a disorder characterized by systemic activation of blood coagulation, which may cause abnormal clotting and bleeding; D-Dimer levels are typically elevated.

• Severe Trauma or Surgery: Post-surgical or traumatic patients may exhibit increased D-Dimer due to activation of the coagulation cascade.

• Inflammatory Conditions: Certain inflammatory diseases can also result in elevated D-Dimer.

• Pregnancy: Pregnancy can influence D-Dimer levels, often causing an increase.

Note: Elevated D-Dimer is a non-specific marker and does not exclusively indicate thrombosis. Further diagnostic procedures and clinical correlation are essential for accurate diagnosis.

Specifications

Product Name: D-Dimer Rapid Test Kit

Sample Type: Whole blood or plasma

Packaging: 1 test/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiry Date: 2026-09-30

Kit Contents

• 1 Test cassette

• 1 Disposable pipette

• 1 Buffer solution

• 1 Lancet for finger prick

• 1 Alcohol wipe

• 1 User manual in English

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control identifier. For best results, conduct the test within one hour of opening the pouch.

2.A For serum or plasma samples:

Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μL) into the sample well (S) on the test cassette, then start the timer.

2.B For whole blood samples:

Hold the pipette vertically and dispense 3 drops of blood into the sample well (S), then add 1 drop of buffer solution (approx. 40μL) and start the timer.

Avoid air bubbles entering the sample well (S), and do not apply any solution onto the result area. During the process, color will migrate along the membrane.

3. Wait for the colored lines to appear. Read the result after 10 minutes. Results read after 20 minutes are invalid.

Performance

• Positive agreement with EIA: 98.7% (95% CI: 96.91% - 100%)

• Negative agreement with EIA: 89.3% (95% CI: 84.34% - 94.26%)

• Overall agreement with EIA: 94.04% (95% CI: 91.36% - 96.72%)

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions