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NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified

NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified

  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
  • NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO13485
Model Number: NT-proBNP
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50-2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 10 Days
Payment Terms: L/C, T/T
Supply Ability: 30000 Kits per Week
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Detailed Product Description
Product Name: NT-proBNP Rapid Test Kit Sample Buffer: 25 Vials
Storage: Room Temperature Specimen: WB/Serum/Plasma
Measure Range: 20-35000pg/ml Format: Cassette
Advantage: High Sensitivity Application In: WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Manufacturer: WWHS Biotech INC Packaging: 20 Tests
High Light:

ISO13485 POCT Test Kit

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35000pg/ml POCT Test Kit

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NT-proBNP 35000pg/ml POCT Test Kit

【Product name】

N-terminal prohormone of brain natriuretic peptide (NT-proBNP) Rapid Quantitative Test(Fluorescence immunoassay)

 

【Package specification】

  25 Tests/kit

 

【Intended use】

This kit is used for quantitative determination of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood and plasma.

 

【Inspection principle】

The principle of immunofluorescence chromatography was applied to the kit. The NT-proBNP antigen in the sample was first bound with the conjugated compound of fluorescent labeled NT-proBNP monoclonal antibody, then moved and combined with another NT-proBNP 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 N-terminal prohormone of brain natriuretic peptide (NT-proBNP) monoclonal mouse antibody), nitrocellulose membrane (coated with N-terminal prohormone of brain natriuretic peptide (NT-proBNP) 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 18 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.

 

【Test 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 100µL of patient sample with 300µL of sample diluent. Apply 100µL 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】

Healthy subjects under 75 years old have assay values below 347pg/mL. Healthy subjects over 75 years old have assay values below 449pg/mL.

 

【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 NT-proBNP concentration lower than 18pg/mL and higher than 35000pg/mL, the detection results are reported as "< 18pg/mL " and ">35000pg/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 NT-proBNP in the sample is less than 35000pg/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 18pg/mL.

2. Accuracy,The relative deviation from the target value is within ±10%.

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

4. Linear range,Within the linear range (20-35000pg/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.

NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified 0NT-proBNP Rapid POCT Test Kit 20-35000pg/ml ISO13485 Certified 1

 

 

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.

 

 

 

About WWHS Biotech Inc

 

WWHS Biotech. Inc Is A High-Tech Enterprise Incubated By The Research Institute Of Tsinghua University In Shenzhen In 2016. The Company Is Located In The National Biomedical Industrial Base In Pingshan District, Shenzhen, With About 32,000 Square Feet Space For Workshop And Office.

 

As A Fast-Growing Biotechnology Company, We Dedicate To The Development Of World-Class Bio-Detection Technologies That Meet The Ever-Increasing Demands On Clinical Diagnostics. We Focus On Developing Cost-Effective And Precise Rapid Diagnostic Products Based On Our Unique Near Infrared (NIR) Fluorescence Platform Technologies (PGOLD And IR-LF) With Major Interests In Cardiology, Infectious Diseases, Oncology, Metabolic Diseases And Women And Children’s Health.

 

FAQ


Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.

 

Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.

 

Q: How about your delivery time?
A: 2~10 day depends your order quantity.

 

Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.

 

Q: What is your terms of payment?
A: China Trade Assurance, T/T in advance, L/C, Western union, paypal
Please suggest your preferred payment method.

 

Q: Do you have certification?

A: ISO13485, CE

 

Q: Do you test all your goods before delivery?

A: Yes, we have 100% test before delivery

 

Q:How about after-sale serive ?
A:We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible .

 

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