D-Dimer Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use.

D-Dimer rapid test for the assessment of deep vein thrombosis and pulmonary embolism

The D-dimer rapid test is intended for the qualitative detection of D-dimer in human whole blood and plasma. The test is used as an aid in the investigation and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT) and pulmonary embolism (PE). An elevated D-dimer level generally indicates activation of the coagulation process, and the results may help physicians in the following cases:

1. Venous thrombosis and embolism: D-dimer levels may be elevated in venous thrombosis (e.g. deep vein thrombosis) and pulmonary embolism.
2. Disseminated intravascular coagulation (DIC): DIC is a condition in which coagulation factors are activated in an uncontrolled manner, leading to abnormal blood clotting. D-dimer levels may also be elevated in DIC.
3. Severe injuries or surgery: D-dimer levels may also be elevated after severe injuries or surgery, as these factors can activate the coagulation system.
4. Inflammatory conditions: Certain inflammatory diseases can also cause elevated D-dimer levels.
5. Pregnancy: Pregnancy can also affect D-dimer levels, which may be elevated in pregnant women.

The D-dimer rapid test is not specific; an elevated D-dimer level may be only one sign of activation of the coagulation system and does not necessarily mean that thrombosis or another problem is present. Therefore, physicians generally order further examinations and take the patient’s clinical condition into account in order to establish a more accurate diagnosis. The test kit can be ordered for professional use.

D-Dimer rapid test specification

Product name: D-Dimer Rapid Test Kit
Sample: whole blood/plasma
Packaging: 1 pc/box
Format: Cassette test
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: 31/08/2028

D-Dimer rapid test kit contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol wipe
• 1 instructions for use in Hungarian

How to use the lancet

1. Take the yellow single-use lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be released automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended solely for healthcare professionals. The product is not intended for self-testing.

Test procedure

Read the Instructions for Use carefully before performing the test. Before testing, allow the test, the sample and/or the controls to reach room temperature (15-30°C).

1. Remove the test from the sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2.A Place the test device on a clean and level surface.

Transfer 2 drops of whole blood or 1 drop of plasma to the sample well (S) of the device using the supplied disposable pipette, and add 1 drop of buffer. Start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any solution to get onto the result area.

2.B Place the test device on a clean and level surface.

Allow 2 drops of fingertip whole blood to fall into the center of the sample well (S) of the test device, then add 1 drop of buffer. Start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any solution to get onto the result area.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

D-Dimer rapid test performance

• Positive agreement with EIA: 151/(151+2) = 98.7% (96.91% - 100%)*
• Negative agreement with EIA: 133/(133+16) = 89.3% (84.34% - 94.26%)*
• Overall agreement with EIA: (151+133)/(151+2+133+16) = 94.04% (91.36%-96.72%)*
  * 95% confidence interval

The test may only be used by qualified professionals and healthcare workers. Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Under Hungarian Government Decree No. 45/2014 (II. 26.), for health protection or hygiene reasons this product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer’s right of withdrawal) e) in respect of a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for the fulfillment of the legal obligations related to the Buyer’s procurement procedure, as this falls within the Buyer’s responsibility; its liability is limited solely to the information on intended use and to the goods delivered.