Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE
Model Number:
NT-proBNP
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【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】
【Test procedure】
【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】
【Limitations of methods】
【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.
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. |
Inflammation | ||||||
10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
Thyroid Hormone | ||||||
15 | TSH | Serum/Plasma | 15min. | 0.3-100mU/L | 0.35-5mU/L | hyperthyroidism and hypothyroidism |
16 | TT3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
17 | TT4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
18 | FT3 | Serum/Plasma | 15min. | 1-100pmol/L | 4-10pmol/L | thyroid dysfunction |
19 | FT4 | Serum/Plasma | 15min. | 5-300pmol/L | 19-39pmol/L | thyroid dysfunction |
Tumor Marker | ||||||
20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
21 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
22 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
23 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
24 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
25 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
29 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
30 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
31 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
32 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
33 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
Fertility | ||||||
34 | HCG / β-HCG | Serum/Plasma | 10min. | 5-20000mIU/ml | <5 mIU/mL | early pregrancy. |
35 | AMH | Serum/Plasma | 10min. | 0.1-16ng/ml | Male: 20-60 years old, 0.92-13.89 ng/mL Female: 20-29 years old, 0.88-10.35 ng/mL 30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL |
ovarian reserve level |
Gastrointestinal | ||||||
36 | FOB | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
37 | TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
38 | FOB+TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
Infection | ||||||
39 | C.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | CP infection |
40 | M.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | MP infection |
41 | Covid-19 Antigen | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
42 | Covid-19 Ab IgG/IgM | WB/Serum/Plasma | 15min. | qualitative | qualitative | respiratory tract |
43 | FluA | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
44 | FluB | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
Renal Injury | ||||||
45 | CysC | WB/Serum/Plasma | 5min. | 0.4-9mg/L | 0.5-1.1mg/L | renal function |
46 | NGAL | Urine | 10min. | 10-1500ng/mL | <132ng/mL | acute kidney injury. |
Other | ||||||
47 | FERR | Serum | 5min. | 10-500ng/ml | Male:24ng/mL~335ng/mL, Female:11ng/mL~307ng/mL |
iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia |
48 | HbA1c | WB | 10min. | 4%-14% | 4%-6% | diabetes |
49 | VD | Serum/Plasma | 15min. | 8-70ng/mL | 19-57ng/mL | fetation |
Notice
1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.
6) The product test results for reference only, for confirmation, please refer to the relevant national standard methods.
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 payment method?
We usually accept the payment methods include PayPal, TT, and Western Union.
50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.
5. 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.
Send your inquiry directly to us