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D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit

D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit

  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
  • D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
D-Dimer Rapid Test Kit IFA Colloidal Gold IVD Blood Diagnostic kit
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: CE
Model Number: D-D
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50 - 2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 7 Days
Payment Terms: T/T
Supply Ability: 50000 Kits per Week
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Detailed Product Description
Product Name: D-Dimer Rapid Quantitative Test Kit Reaction Time: 10 Min.
Feature: High Sensitivity Quantity: 25T
Storage: 4-30℃ Manufacturer: WWHS Biotech INC
Application In: WWHS NIR-1000 Dry Fluoroimmunoassay Analyser Throughput: 6000 Tests/Day
Sample Type: WB / Plasma Keywords: High Stability, High Accuracy
High Light:

D-Dimer Rapid Test Kit

,

IFA Blood Diagnostic kit

,

IVD Blood Diagnostic kit

【Product name】

D-Dimer Rapid Quantitative Test(Fluorescence immunoassay)

【Package specification】

20 Tests/box

【Intended use】

This kit is used for quantitative determination of D-dimer in human whole blood and plasma.

【Inspection principle】

The principle of immunofluorescence chromatography was applied to the kit. The D-dimer antigen in the sample was first bound with the conjugated compound of fluorescent labeled D-dimer monoclonal antibody, then moved and combined with another D-dimer monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Main components】

Name Quantity Component
Test card 25 It is composed of fluorescent pad (coated with fluorescent labeled D-dimer monoclonal mouse antibody), nitrocellulose membrane (coated with D-dimer monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing
Sample buffer 25(300μL/tube) Phosphate buffer
ID card 1 Record the standard curve information of this kit
 

The components in different batches of kits cannot be used interchangeably.

【Storage conditions and validity】

The test card should be stored at 4℃~30℃, dry, dark and no freezing. It should be stored in sealed aluminum foil bag and valid for 12 months. The test card should be returned to room temperature (15℃~30℃) before opening. It should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.

【Applicable instruments】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

【Sample requirements】

  1. The sample types of this product are EDTA·K2 anticoagulant plasma, EDTA·Na2 anticoagulant plasma, sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9), EDTA·K2 anticoagulant whole blood, EDTA·Na2 anticoagulant whole blood and sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9).
  2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
  3. After clinical samples were collected, the detection was completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored for 24 hours at 2℃~8℃; Plasma samples can be stored at 2℃ to 8℃ for 7 days; The plasma sample was at - 20℃. It can be stored for 30 days at room temperature.
  4. Before testing, the sample must return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use, and repeated freezing and thawing should be avoided.

【Procedure】

  1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
  2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed; Otherwise, the cause should be found out before testing.)
  3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
  4. Place the test card on a clean horizontal table and mark it horizontally.
  5. Mix 10 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, press the [timing detection] key, automatically time for 10 minutes, automatically judge the test results, and display the quantitative results on the screen. Or insert the test card into the analyzer after timing for 10 minutes, and press the [real time detection] key, and the instrument will automatically interpret the test results.

【Reference interval】

By measuring 268 healthy people aged between 19 and 79, statistical analysis shows that the reference interval is less than 500 ng/ml. According to the characteristics of the local population, the reference intervals of the laboratories were established.

【Interpretation of results】

  1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
  2. For samples with D-dimer concentration lower than 40ng/ml and higher than 10000ng/ml, the detection results are reported as "< 40ng/ml" and "> 10000ng /ml", respectively.

【Limitations of methods】

  1. This kit is only used to detect human plasma/whole blood samples
  2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
  3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
  4. When the concentration of D-dimer in the sample is less than 20000ng/ml, there is no hook effect.
  5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
  6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.

【Performance】

1. Analysis sensitivity

No more than 40ng/ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (40 ~ 10000ng/ml), the linear correlation coefficient R≥0.990.

【Note】

1. This kit is only used for in vitro diagnosis.

2. The test card and sample diluent are disposable and cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃~30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.

5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.

Assay list          
Cardiac          
cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Intended Use
1 cTnI WB/Serum/Plasma 12min. 0.1-40ng/ml <0.3ng/ml several heart diseases including myocardial infarction and heart failure.
2 Myo WB/Serum/Plasma 12min. 5-400ng/ml <58ng/ml acute myocardial infarction (AMI) in early stage.
3 CK-MB WB/Serum/Plasma 12min. 1-200ng/ml <5ng/ml acute myocardial infarction (AMI) in early stage.
4 NT-proBNP WB/Serum/Plasma 10min. 20-35000pg/ml Under 75:0~347pg/mL,
Over 75:0~449pg/mL
heart failure .
5 D-Dimer WB/Plasma 10min. 40-10000ng/ml <500ng/ml disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.
6 cTnI+Myo+CKMB WB/Serum/Plasma 12min. same with single item same with single item Triple marker of myocardial infarction.
7 ST2 WB/Serum/Plasma 10min. 10-400ng/ml <35ng/ml heart failure .
8 Lp-PLA2 WB/Serum/Plasma 10min. 10-900ng/ml <175ng/ml Risk evaluation of ACS and atherosclerotic ischemic stroke patients.
9 S100-β WB/Serum/Plasma 10min. 0.05-10ng/ml <0.2ng/ml Cerebral infarction, cerebral injury.

 

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Application In

 

NIR-1000 Dry Fluoroimmunoassay Analyser

 

Wide-Range Diagnostics, It can be used in following areas:

1) Department of thoracic Surgery

2) Clinical Laboratory

3) Department of Emergency

4) First Aid Community Hospital

5) Department of Respiration

6) CCU/ICU

7) Department of cardiology

8) Department of Geriatrics

 


About Payment:

 

1. We accept the T/T, 30% as deposit, and the rest should be payed before shipment.

2. L/C is welcome when the account is too large.

3. Our price is often FOB shenzhen, or FOB shenzhen airport, and EXW, CIF, and so on.

4. We normally ship by Shenzhen.All products shipped with careful packaging to protect and ensure safety of contents during shipment.

5. We do not responsible for any custom taxation if applicable in some country.

6. We do everything to provide you the most reliable way of shipping service. Yet sometimes international delivery is highly depended on the local customs and post service.


Advantage:

 

1. Advanced Quality: We have strict quality control system and enjoy good reputation in the market.

2. Sincerly Service: We treat clients as friend and aims at building long term business relatiionship.

 

FAQ:


Q. How is your company's product after-sales service system?
A. The product warranty period is 12 months, we can provide lifetime maintenance. We have professional pre-sales and after-sales teams that can respond to you within 24 hours to resolve technical issues. We provide one-to-one after-sales service.

 

Q: Can you customize it?
A: Yes, we accept customization according to customer's specific requirements.

 

Q. How long is your lead time? If I want to customize instruments, how long will it take?
A. When order quantity is 1-10 units, we have ready stock goods, we can ship out within 3-5 working days after receipt of deposit; products required new production of common materials, usually the lead time is about 10-15 days; products requiring new production of special and rare materials, usually the lead time is about 20-30 days.

Most Of FIA Rapid Test Cassette Assay Such As Cardiac and Inflammation Items Are Available For 5-10 days Prompt Shipment.

 

Q. What payment method do you accept?
A. Our company accept payment method of T/T (bank transfer), Western Union, PayPal and so on.

 

Q. What package do you use for your products? What shipping method do you use?
A.1. Our company use standard exporting carton for packing. 2. We ship via express courier (door to door service), by air, and by sea according to customers' requirements.

For more questions, please feel free to send inquiries to us.

Contact Details
WWHS Biotech.Inc(exclusive marketed by Dawin)

Contact Person: sales

Tel: +8613823276027

Send your inquiry directly to us (0 / 3000)

Contact

Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen