Professional Manufacturer of Rapid Test Devices
Place of Origin: | China |
Brand Name: | Newscen |
Certification: | ISO9001, CE, TUV, FDA |
Model Number: | CEA |
Minimum Order Quantity: | 10 Boxes or 400 Kits (40 Kits/Box) |
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Price: | Negotiable as per Order Quantity |
Packaging Details: | 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm |
Delivery Time: | 8 days |
Payment Terms: | T/T, Western Union, MoneyGram |
Supply Ability: | 100,000 Kits Per Day |
Specimen: | Serum, Plasma, Whole Blood | Methodology: | Colloidal Gold |
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OEM/ODM: | Acceptable | Category: | Cancer Detection |
Result Time: | Read In 20 Minutes | Box Color: | Brown |
High Light: | 20uL Whole Blood Cancer Testing Kit,fingertip Specimens AFP Testing Kit,20uL Whole Blood AFP Testing Kit |
Alpha Fetoprotein (AFP) Quantitative Rapid Test Kit (Colloidal Gold)
For the quantitative detection of AFP in serum/plasma/whole blood
Alpha Fetoprotein Quantitative Rapid Test Kit For Cancer Testing Kit Tumor Marker Rapid Test Kit
Intended Use
Alpha fetoprotein (AFP) quantitative rapid test kit (colloidal gold) is a chromatographic immunoassay (CIA) for the quantitative detection of AFP in serum/plasma and whole blood. It is used in conjunction with the Rapid Immuno Assay Reader.
Principle
Alpha fetoprotein (AFP) quantitative rapid test kit (colloidal gold), is a double antibody sandwich immunoassay kit for the quantitative testing of AFP in serum, plasma and whole blood. The membrane was precoated with AFP specificity antibodies on the test band region and Goat anti-mouse IgG antibody on the control band region.
During the test, the specimen is allowed to react with matched AFP Specific antibodies -colloid gold conjugate, which was predried on the test strip. The conjugate binds to the AFP forming an antibody-antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by AFP Specific antibodies on the test region to produce a visual pink color band.
Regardless of the presence of AFP, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized Goat anti-mouse IgG antibodies to form a distinct pink colored control band. Coordinate with the Standard curve line of Rapid Immuno Assay Reader to read the content of AFP.
Composition
The test kit contains AFP Specific antibodies on a colloid gold particles and a combination of AFP Specific antibodies on the membrane.
Assay Procedure
1. Bring the test and specimens to room temperature. Remove the test card from the foil pouch and place on a clean dry surface.
2. Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃ stored specimen to room temperature for test.
3. Remove the sample diluent, blending and set aside.
4. Test & Read: suck 10μL of serum/plasma samples or 20μL of whole blood samples with pipette into S Well, add 80μL of buffer into B well. After 15~20 minutes read the test result by Rapid Immuno Assay Reader. If read the result more than 20 minutes, the results are invalid.
5. Calibration: before read the result, need to confirm that the Reader is in normal state. And the Reader passes the daily photometric calibration. Moreover, download the standard curve, import the IC as interpretation of the reagent .
Interpretation of Results
1. Test results are in the reference range, indicates that the body does not take place any diseases related to AFP abnormal expression.
2. The test results is higher than the reference value, indicates that there is abnormal expression of AFP in the body. There may be some pathological changes or physical abnormalities, such as acute and chronic hepatitis, cirrhosis, some embryonal carcinoma, germ cell tumors, digestive tract cancer and pregnancy,causing abnormal increase of AFP. AFP rise could not determine the specific cause.
3. The results > 400ng/mL, indicates that the content of AFP in sample is higher than the upper limit of the test range. Recommend repeat testing after appropriate dilution, until you can get the specific concentration values, multiplied by the dilution factor is the sample concentration. The best dilution multiples is 10 times.
4. Invalid result, no control line observed, retest required.
Quality Control
Alpha fetoprotein (AFP) quantitative rapid test kit (colloidal gold) has included a procedural control in the test. If a test kit is valid and assay was performed properly a pink colored band will always appear in the membrane regardless the test result.
Reagents And Materials Provided
1. One pouched cassette with desiccant.
2. One instruction.
3. One bottle of buffer.
Materials Required But Not Provided
1. Clock or Timer
2. Centrifuge tube
Warning and Precautions
1. FOR PROFESSIONAL USE AND IN VITRO DIAGNOSTIC USES ONLY
2. Do not reuse the test devices. Discard it in the dustbin after single use.
3. Do not touch the membrane locate in the windows.
4. Do not use the test one hour after the pouch was opened.
Storage
The kits should be stored at a cool dark place at temperature 4-30°C and, the sealed pouch for the duration of the shelf life (24 months).
Contact Person: Mr. Randy.Zhang
Tel: 008618611273771