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Alpha Fetoprotein (AFP) Rapid Quantitative Test (Fluorescence immunoassay)
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.
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.
|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
|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.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc
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】
【Limitations of methods】
1. Limits of detection
No more than 2.5ng /ml.
The relative deviation from the target value is within ±15%.
The within and between assay coefficient of variations are within 15%.
Within the linear range (2.5~ 200ng/ml), the linear correlation coefficient R≥0.990.
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
|WWHS Assay list
|colon cancer, colorectal cancer,etc.
|non-small cell lung cancer
|Abnormal recessive gastrointestinal bleeding
|< 25 U/mL
|< 27 U/mL
|Early pregrancy, ectopic HCG cancer,incomplete abortion
|non-small cell lung cancer
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%.
1. What is fluorescent immunoassay analyzer?
The Biopanda Fluorescence Immunoassay Analyser is used by small labs for the detection of a range of biomarkers to assist with the diagnosis and monitoring of several medical conditions including cardiovascular disease, inflammation, kidney disease, thyroid conditions, and fertility.
2. Do you have CE certificate for immunoassay analyzer?
WBC analyzer belongs to IVD other/general, no need CE, Ec declaration is enough.
3. How does fluorescence immunoassay work?
Fluorescent Immunoassays are simply a different type of immunoassay. ... A modern fluorescent based immunoassay uses as the detection reagent a fluorescent compound which absorbs light or energy (excitation energy) at a specific wavelength and then emits light or energy at a different wavelength.
4. What is indirect immunofluorescence assay?
Indirect immunofluorescence, or secondary immunofluorescence, is a technique used in laboratories to detect circulating autoantibodies in patient serum. It is used to diagnose autoimmune blistering diseases.
5. Is immunofluorescence an immunoassay?
Immunofluorescence assay (IFA) is a standard virologic technique to identify the presence of antibodies by their specific ability to react with viral antigens expressed in infected cells; bound antibodies are visualized by incubation with fluorescently labeled antihuman antibody.
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