manufacturer Cardiac marker D-Dimer rapid test kits

manufacturer Cardiac marker D-Dimer rapid test kits

INTENDED USE

D-Dimer Rapid Test Device is used for the qualitative detection of D-dimer in human whole blood and plasma; The test is used as an aid in the assessment and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE).

INTRODUCTION

During blood coagulation process, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerise to form a soluble gel of non-cross-linked fibrin. This fibrin gel is then converted to cross-linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed. Although fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, only degradation products from cross-linked fibrin contain D-dimer and are called cross-linked fibrin degradation products. Therefore, fibrin derivatives in human blood or plasma containing D-dimer are a specific marker of fibrinolysis.

KIT COMPONENTS

Materials Provided

1.Test devices

a. Disposable pipettes

b.Buffer 

2.Package insert

PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

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

OR

 3. Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and add 1 drop of buffer. Start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

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

Packing Details : Standard packing ,neutral packing, your requirement are available
Delivery Details : 7-25 days after receiving the 30% deposit

Shipping Details : DOOR TO DOOR, BY AIR, BY SEA etc.
Payment Details :T/T,Western Union and Paypal are available.

After service:

 1.Service tenet: quick and decisive and thoughtful thorough and accurate;

2.Service objectives: service quality to win customer satisfaction;

3.Service efficiency:   We will have a dedicated staff to detect problems with the product for testingf  if you are not satisfied when you receive your goods, and promptly get back to you within 24 hours.

4.Service principles: products in the course of product issues caused by improper operation, we will provide a solution.

Q1.What's the method you use to do the test?

A: Colloidal Gold Method.

Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 2000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.  

Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.

Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.

Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.

Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts: 
1. Technical data: Such as the accuracy, specificity and sensitivity.
2. Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
3. Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
4. Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.