Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
PCT
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[Product Name]
Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)
[Packing Specification]
25 Tests/kit
[Intended Use]
The product is used to determine the content of procalcitonin (PCT) in whole blood, plasma and serum of human body and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.
[Test Principle]
The kit uses immunochromatographic assay. First, PCT antigen in the sample combines with the fluorescently-labeled PCT monoclonal antibody conjugate. Then, it continues to move and combines with another PCT monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.
[Main Ingredients]
Name | Loading capacity | Ingredient |
Test card | 25 | The product consists of fluorescent mat (coated with fluorescently-labeled PCT monoclonal murine antibody), nitrocellulose membrane (coated with PCT monoclonal murine antibody and goat anti mouse IgG antibody), absorbent paper and bottom lining. |
Sample diluent | 25 | Phosphate buffer |
ID card | 1 | Record standard curve information of this batch of reagents |
Ingredients of kits of different batch numbers cannot be exchanged.
[Storage Conditions and Validity]
The product should be stored at 4℃-30℃ in a dry and dark place, sealed using aluminum foil bag and must not be frozen. The storage life is 12 months. The test card should be unpacked at room temprature (15℃-30℃) and should be used in 15min after unpacked at a temperature of (15-30)℃ and relative humidity of 20%-90%.
See outer packing for production date, batch number and expiry date.
[Applicable Instrument]
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
[Sample Requirements]
[Test Method]
【Reference Interval】
Determine 254 healthy people aged 18-68 and carry out statistical analysis. Result shows that the upper limit of the reference value is 0.5ng/mL at the 95th percentile, so the reference interval is less than 0.5ng/mL.
The laboratory should establish a reference range according to characteristics of local people.
[Interpretation of Test Results]
1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose PCT concentration is lower than 0.2ng/mL and higher than 100ng/mL, test result is “<0.2ng/mL” and “>100ng/mL” respectively.
[Limitation of Test Method]
1. The kit can be used to test whole blood, plasma and serum specimens of human body only.
2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.
5. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.
6. When RF concentration of samples is less than 2000 IU/mL, the test result will not be affected.
[Product Performance Indicators]
No more than 0.2ng/mL
The relative deviation to the target value is limited to ±15%.
Within-run precision CV≤15%; between-run relative limit R≤15%.
Within the specified linearity range (0.2-100) ng/mL, linearly dependent coefficient r≥0.990.
【Precautions】
WWHS 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 |
Interpretation of Test Results
1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “<0.1ng/mL” and “>40ng/mL” respectively.
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