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

Product Specification

【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.

【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.

【Main components】

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.

【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.
 

【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.

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 .