Professional Manufacturer of Rapid Test Devices
|Place of Origin:||China|
|Certification:||ISO9001, CE, TUV, FDA|
|Minimum Order Quantity:||10 Boxes or 400 Kits (40 Kits/Box)|
|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|
|Category:||Cancer Detection||Methodology:||Colloidal Gold|
|Format:||Cassette / Strip||OEM/ODM:||Available|
|Usage:||For In Vitro Diagnostic Use Only||CE Certificate:||YES|
Double Antibody AFP Testing Kit,
Plasma Alpha Fetoprotein testing kit,
10uL Plasma AFP Testing Kit
Alpha Fetoprotein (AFP) Quantitative Rapid Test Kit (Colloidal Gold)
For the quantitative detection of AFP in serum/plasma/whole blood
AFP Fast Detection For Cancer Alpha Fetoprotein on Tumor Marker Rapid Test Kit
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.
AFP is a kind of protein ,molecular weight of about 69 KD, mainly produced primarily by the fetal liver. Normally, AFP levels decline rapidly after birth, reaching undetectable levels (less than 10ng/ml) within several months after birth. Levels of AFP in adults are normally low.
Certain pathological or physiological abnormalities, such as acute and chronic hepatitis, liver cirrhosis, and certain embryonal carcinoma, germ cell tumors, digestive tract cancer and pregnancy will cause abnormal increase of AFP concentration. Because a rising AFP level cannot indicate specific pathogenesis, the reagents only used in the detection of abnormal changes of AFP.
The test kit contains AFP Specific antibodies on a colloid gold particles and a combination of AFP Specific antibodies on the membrane.
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.
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).
Fingertip Specimens (Whole Blood)
1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipette to obtain a moderate amount of fresh blood.
1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store sample in 5 days at 4°C. Plasma may be frozen at -20°C for up to 3 months.
1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store sample in 5 days at 4°C. Serum may be frozen at -20°C for up to 3 months.
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.
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.
Analysis sensitivity: 20ng/mL
Analysis Specificity: There is no cross-reaction with 150ng/mL carcinoembryonic antigen (CEA), 120ng/mL prostate specific antigen (PSA), 500ng/mL ferritin (SF) .Test result is less than 10ng/mL.
Accuracy: With a series of internal control product concentration was measured, and the measured value of each quality control point calibration deviation should not exceed ± 15%
Dose - response curve: In 0-400ng/mL detection range, correlation coefficient r should be no less than 0.975. Absolute deviation of two low control point (0ng/mL& 20ng/mL )is no more than ±0.5, relative deviation of control point 50ng/mL,100ng/mL, 200ng/mL and 400ng/mL is no more than ±15%.
Intra-assay imprecision: Parallel tested precision internal enterprise products, repeat 10 times; the coefficient of variation (CV) should not be higher than 15%.
Inter-assay imprecision: Parallel tested precision internal enterprise products, repeat 10 times; the coefficient of variation (CV) should not be higher than 20%.
Contact Person: Mr. Randy.Zhang