CITEST DIAGNOSTICS INC.

China,Hangzhou ,Zhejiang
Verified Supplier

Send Email



Leave a Message

we will call you back quickly!

Submit Requirement

Home>
LF Reader>
D Dimer Rapid Test LF Reader Semi Quantitative Diagnosis Of DIC DVT PE

China D Dimer Rapid Test LF Reader Semi Quantitative Diagnosis Of DIC DVT PE





D Dimer Rapid Test LF Reader Semi Quantitative Diagnosis Of DIC DVT PE

MOQ： N/A
Price： Negotiation
Get Latest Price


Delivery Time	2-4 Weeks
Packaging Details	10T
Product	D-dimer Rapid Test with LF Reader,Semi-Quantitative Rapid Tests,diagnosis of DIC/DVT/PE
Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	WB/P
Certificate	CE
Reading Time	10 minutes
Pack	10T
Storage Temperature	2-30°C
Shelf Life	2 Years
Sensitivity	97.2%
Specificity	94.0%
Accuracy	96.4%
Cut-Off	350-5000 ng/mL
Brand Name	Citest
Model Number	CDM-R402
Certification	CE
Place of Origin	-

View Detail Information

Contact Now Ask for best deal

Get Latest Price Request a quote

Explore similar products

10 Seconds Stable Citest LF Reader 8GB Internal Memory

Get Latest Price
Procalcitonin PCT Rapid Test Cassette Quantitative Chromatographic Immunoassay

Get Latest Price
Citest Fast LF Reader Sensitive Accurate Calprotectin FOB Rapid Test Reader

Get Latest Price
FHC-R102 Hcg Rapid Test Reader Convenient Rapid Pregnancy Test Kit

Get Latest Price

Product Details
Company Details

Product Specification


Delivery Time	2-4 Weeks	Packaging Details	10T
Product	D-dimer Rapid Test with LF Reader,Semi-Quantitative Rapid Tests,diagnosis of DIC/DVT/PE	Principle	Chromatographic Immunoassay
Format	Cassette	Specimen	WB/P
Certificate	CE	Reading Time	10 minutes
Pack	10T	Storage Temperature	2-30°C
Shelf Life	2 Years	Sensitivity	97.2%
Specificity	94.0%	Accuracy	96.4%
Cut-Off	350-5000 ng/mL	Brand Name	Citest
Model Number	CDM-R402	Certification	CE
Place of Origin	-
High Light	D dimer Rapid Test LF Reader ，DVT PE LF Reader ，Semi Quantitative Diagnosis Of DIC

Product features	Parameters
Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	WB/P
Certificate	CE
Reading Time	10 minutes
Pack	10 T
Storage Temperature	2-30°C
Shelf Life	2 Years
Sensitivity	97.20%
Specificity	94.00%
Accuracy	96.40%
Cut-Off	350-5000 ng/mL

D-dimer Rapid Test Cassette(Whole Blood /Plasma) D-dimer Rapid Test with LF Reader,Semi-Quantitative Rapid Tests,diagnosis of DIC/DVT/PE

A rapid test for the qualitative detection of D-dimer in whole blood or plasma that can be performed with the use of the LF Reader.

For professional in vitro diagnostic use only.

INTENDED USE

The D-dimer Rapid Test Cassette (Whole Blood/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of D-dimer in whole blood or plasma as an aid in the diagnosis of Disseminated Intravascular Coagulopathy (DIC), deep venous thrombosis (DVT) and pulmonary embolism (PE) that can be performed with the use of the Reader.

SUMMARY

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. It is so named because it contains two cross linked D fragments of the fibrin protein. D-dimer concentration may be determined by a

blood test to help diagnose thrombosis. Since its introduction in the 1990s, it has become an important test performed in patients with suspected thrombotic disorders. While a negative result practically rules out thrombosis, a positive result can indicate thrombosis but does not rule out other potential causes. Its main use, therefore, is to exclude thromboembolic disease where the probability is low. In addition, it is used in the diagnosis of the disorder Disseminated Intravascular Coagulopathy.

The D-dimer Rapid Test Cassette (Whole Blood/Plasma) is a simple test that utilizes a combination of anti- D-dimer antibody coated particles and capture reagents to semi-quantitatively detect D-dimer in whole blood or plasma. The minimum detection level is 500ng/mL.

PRINCIPLE

The D-dimer Rapid Test Cassette (Whole Blood/ Plasma) is a qualitative, membrane based immunoassay for the detection of D-dimer in whole blood or plasma. The membrane is pre-coated with specific capture antibodies in the test line region of the test. During testing, the whole blood or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture antibodies on the membrane and generate a colored line.

The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND PREPARATION

The D-dimer Rapid Test Cassette (Whole Blood/ Plasma) can be performed using whole blood (from venipuncture or fingerstick) or plasma.

To collect Fingerstick Whole Blood specimens:

Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.

Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood.

Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.

Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:

Touch the end of the capillary tube to the blood until filled to approximately 25uL. Avoid air bubbles.

Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood to the specimen area of the test cassette.

To collect Whole Blood from venipuncture:

Collect blood from venipuncture with the anticoagulants tube (EDTA, Heparin, Citrate and Oxalate) and use it directly for the test.

Separate plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.

Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Plasma specimens may be stored at 2-8°C for up to half-day, for long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within half day of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

DIRECTIONS FOR USE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.

2. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

3. Place the cassette on a clean and level surface.

For Plasma specimen:

Hold the dropper vertically and transfer 1 drop of plasma (approximately 25uL) to the specimen well, then add 2 drops of buffer (approximately 80uL), and start the timer.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 1 drop of whole blood (approximately 25uL) to the specimen well, then add 2 drops of buffer (approximately 80 uL), and start the timer.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 25 uL of fingerstick whole blood specimen to the specimen well of test cassette, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.

4. Wait for the colored line is appeared. The result should be read with the LF Reader

at 10 minutes.

5. Do not interpret test results visually.

6. For the LF Reader installation, start up and complete instructions refer to the LF Reader User Manual. Operator must consult the LF Reader User Manual prior to use and become familiar with the processes and quality control procedures.

Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

421 clinical specimens with known status of D-dimer above or below cut-off value of 500ng/mL collected from local hospitals were tested with D-dimer Rapid Test Cassette (Whole Blood/Plasma) in house. Results indicated relative sensitivity was 97.2%, relative specificity was 94.0%, and the overall accuracy was 96.4% compared with ITM.

Order Information

Cat. No.	Product	Specimen	Pack
CDM-R402	D-dimer Rapid Test Cassette	WB/P	10T

Company Details

Bronze Gleitlager

Bronze Sleeve Bushings

and

Graphite Plugged Bushings

from Quality China Factory



Business Type:

Manufacturer,Exporter,Trading Company 


Total Annual:

80000000-100000000


Employee Number:

500~10000 


Ecer Certification：

Verified Supplier 

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies. ... CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies. ...

+ Read More

Reach Us
CITEST DIAGNOSTICS INC.
170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
https://www.citesttestkit.com/

Send Email

Leave a Message, we will call you back quickly!