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Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy

Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy

  • Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
  • Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
  • Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
  • Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
  • Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO13485, CE
Model Number: AFP
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: AFP Rapid Quantitative Test Kit Sample Buffer: 25 Vials
Warranty: 12 Months Applicable Instruments: NIR-1000 Dry Fluorescent Immunoassay Analyzer
Type: Tumor Marker Reactivity: Human
Formal Name: Alpha Fetoprotein Storage: At Room Temperature
Item: Chemiluminescence Immunoassay Interface: Auto Chip Cassette Rapid Test
Feature: High Sensitivity, High Accuracy Supply Capacity: 3 Million A Year
High Light:

AFP Rapid Quantitative Test Kit

,

Alpha Fetoprotein Test Kit

,

High Accuracy Tumor Marker Rapid Test

CE Approval AFP FIA POCT Tumor Markers Rapid Quantitative Test Kit

【Product name】

Alpha Fetoprotein (AFP) Rapid Quantitative Test (Fluorescence immunoassay)

【Package specification】

25 Tests/kit

【Intended use】

This kit is used for quantitative determination of AFP in human whole blood, plasma and serum.

Alpha fetoprotein(AFP), the foetal aquivalent to albumin, is a 67kDa glycoprotein produced during embryonic development and found in high concentration in fortal serum and amniotic fluid. In normal non-pregnant adults AFP is present in low concentrations in serum. However AFP may markedly increased in the serum from patients with cancer of the liver, testis or ovary. Quantitative determination of AFP serum may be valuable in the management of patients with suspected or diagnosed liver cancer or germ cell tumors of the testis or ovary.In addition, elevated serum AFP concentration have been measured in patients with other noncancerous,diseases,including ataxia telangiectasia hereditary tyrosinemia neonatal hyperbilirubinemia acuter viral hepatitis, chronic active hepatitis and cirrhosis. Elevated serum AFP concentration are also observed in pregnant woman. Therefore AFP measurement are not recommended for use as a screening procedure to detect the presence of cancer in the general population.

【Inspection principle】

The AFP Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of AFP. The AFP antigen in the sample was first bound with the conjugated compound of fluorescent labeled AFP monoclonal antibody, then moved and combined with another AFP 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.

【Components】

Name Quantity Component
Test cards 25 It is composed of fluorescent pad (coated with fluorescent labeled AFP monoclonal mouse antibody), nitrocellulose membrane (coated with AFP monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing
Sample diluent 25(300μL/tube) Phosphate buffer
ID card 1 With specific stand curve file
 

The components in different batches of kits cannot be used interchangeably.

【Storage conditions and validity】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card 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. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
  2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
  3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
  4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.

【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 100 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.

【Reference interval】

Healthy non-pregnant adults are expected to have serum AFP values below 20ng/ml. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.

【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 AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /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 AFP in the sample is less than 20000ng/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. Limits of detection

No more than 2.5ng /ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

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

4.Linear range

Within the linear range (2.5~ 200ng/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.

 

Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy 0

 

WWHS POCT Assay List

 

Tumor Marker          
cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Intended Use
18 AFP Serum/Plasma 15min. 2.5-200ng/ml <20ng/ml pregnancy cancer
19 CEA Serum/Plasma 15min. 1-200ng/ml <5ng/ml colon cancer, colorectal cancer,etc.
20 NSE Serum/Plasma 15min. 1-400ng/ml <16ng/ml non-small cell lung cancer
21 FOB fecal specimens 10min. 50-1000ng/ml <100ng/ml Abnormal recessive gastrointestinal bleeding
22 PG II Serum/Plasma 15min. 1-100ug/L PGI/PGII>3.0 gastric abnormalities
23 PG I Serum/Plasma 15min. 2.5-200ug/L >70ng/ml gastric abnormalities
24 PSA Serum/Plasma 15min. 0.5-40ng/ml <4ng/ml prostate cancer
25 FPSA Serum/Plasma 15min. 0.1-10ng/ml <1ng/ml prostate cancer
26 CA12-5 Serum/Plasma 15min. 20-500U/ml <35U/ml ovarian cancer
27 CA15-3 Serum/Plasma 15min. 10-400U/ml < 25 U/mL breast cancer
28 HE4 Serum/Plasma 15min. 50-2000pmol/L <140 pmol/L ovarian cancer
29 CA19-9 Serum/Plasma 15min. 10-400U/ml < 27 U/mL pancreatic cancer
30 β-HCG Serum/Plasma 15min. 5-400mIU/ml <10 mIU/mL Early pregrancy, ectopic HCG cancer,incomplete abortion
31 CK19(Cyfra21-1) Serum/Plasma 15min. 0.5-50ng/ml <2.5ng/ml non-small cell lung cancer

 

Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy 1Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy 2

Tumor Marker AFP Rapid Quantitative Test Kit High Accuracy 3

 

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 AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /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 AFP in the sample is less than 20000ng/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%.

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.


Applicable Instrument

 

WWHS NIR-1000 dry fluoroimmunoassay analyser

 

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