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CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic

CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic

IFA IVD Test Kit

NT-proBNP IVD Test Kit

Colloidal Gold IVD Test Kit

Place of Origin:

CN

Brand Name:

WWHS

Certification:

CE

Model Number:

NT-proBNP

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Product Details
Product Name:
NT-proBNP Rapid Test Kit
Type:
One Step Assay
Reactivity:
Human
Formal Name:
N-terminal Prohormone Of Brain Natriuretic Peptide
Package:
25 Tests
Storage:
At Room Temperature
Advantage:
High Sensitivity
Feature:
High Accuracy
Manufacturer:
WWHS Biotech INC
Usage:
Cardiac Detection
Keywords:
High Stability, High Sensitivity
Application:
Clinic Hospital Lab
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
Negotiable
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
T/T
Supply Ability
20000 Kits per Week
Product Description

【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.

 

CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 0

 

Note:


1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay

 

Assay list          
Cardiac          
cat#. Product item Specimen Reaction Time Measure Range Clinical Range Itended 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.

 

CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 1CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 2CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 3CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 4CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 5CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 6CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 7CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 8CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 9CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 10CE NT-proBNP Rapid Test Kit IFA Colloidal Gold IVD Diagnostic 11

 

Why Choose WWHS

 

Our company's main business is INFRARED fluorescent POCT. The main application scenarios of POCT include emergency department, ICU, chest pain center and stroke center, operating room, and various departments of grade hospitals. Community health, outpatient and other primary medical institutions at all levels; Pharmacies, home use and other organizations and individuals targeted at end customers. POCT is characterized by its simplicity and speed, freedom from application scenarios, and high cost performance. However, the current pain point of POCT industry lies in how to solve the problems of low sensitivity and poor precision faced by POCT products.

 

1. Precision
Deviation is less than 3.0%
2. Upgraded data storage
10000 data storage
3. Long life
Support to use 3 years

 

FAQ:

 

1. What is the MOQ?

 

Generally if you choose the different products, our minimum order qty. also will be different. One sample available.

 

2. What about the delivery time?

 

The goods need 7-21 work days to be made upon deposit.

 

3. Does your product have any warranty?

 

Yes, we offer 6 months limited warranty for our products.

 

Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.

 

4. What's your shipping method?

 

We provide comprehensive shipping methods.

 

For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.

 

For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.

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