A CLIA test kit for the quantitative determination of Alpha-fetoprotein (AFP) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Alpha-fetoprotein (AFP) Test Kit (CLIA) is intended for quantitative determination of Alpha-fetoprotein (AFP) in human serum and plasma, used as a serum marker of primary liver cancer for the diagnosis and efficacy monitoring of primary liver cancer clinically.
For professional in vitro diagnostic use only.
【SUMMARY】
Alpha-fetoprotein is an embryo-specific alpha globulin and a single-polypeptide chain glycoprotein. It belongs to the albumin family and has a molecular weight of approximately 70,000 Daltons. AFP and albumintogether constitute the main protein in the fetal circulation, and its synthesis mainly occurs in the liver and yolk sac of the fetus.1 It is secreted into fetal serum, reaching a peak around 13 weeks of gestation, and then gradually decreasing. When the fetus is 2 years old, only a small amount of AFP can be detected normally. If the level of AFP rises, it may appear in certain malignant diseases or pregnant adults.
Studies have shown that in the serum of patients with primary liver cancer and non-spermocyte testicular cancer, the level of AFP will increase.
Changes in AFP levels are helpful for the diagnosis of patients with non-spermatogonial testicular cancer. For example, the combined detection of AFP and human chorionic gonadotropin (HCG) has been used as an important indicator for monitoring the condition of patients with non-spermogenic testicular cancer. 3-5 However, it is not recommended to use AFP for cancer screening in the general population.
In addition, the increase in AFP levels is also related to chronic viral hepatitis, liver cirrhosis and other malignant diseases.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the AFP antibody labeled with alkaline phosphatase, and the magnetic particles coated with the AFP antibody are mixed. After incubation, the AFP in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies.
The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of AFP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of AFP in the sample.
【REAGENTS】
The reagent strip includes AFP antibody coated with magnetic particles, alkaline phosphatase labeled AFP antibody, wash buffer and substrate solution.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Read the entire package insert carefully prior to testing.
3. Do not use after the expiration date indicated on the package.
4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.
5. Do not interchange or mix reagents from different batches.
6. Used test materials should be disposed of in accordance with local regulations.
7. Test kits and samples need to be equilibrated to room temperature before testing.
8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.
9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
10.The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.
11.Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.
12.Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.
13.The Alpha-fetoprotein (AFP) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals
【SPECIMEN COLLECTION AND PREPARATION】
Collect and handle the specimen strictly as below:
1. Collect the specimen according to standard procedures.
2. Human serum collected using standard sampling tubes or tubes containing separating gel.
3. Human plasma collected using EDTA or Heparin sodium.
4. Separate human serum and plasma from blood as soon as possible to avoid hemolysis. Grossly hemolytic, lipidic or turbid samples should not be used. Specimen with extensive particulate should be clarified by centrifugation prior to use. Do not use specimens with fibrin particles or contaminated with microbial growth.
5. Do not leave specimens at room temperature for prolonged periods.
Serum and Plasma specimens may be stored at 2-8 °C for up to 5 days, below -20 °C stable for 3 months.
6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
7. If the patients had been treated by high dose of biotin (5 mg/day), blood collection must be done after at least 8 hours.
8. If specimens are to be shipped, pack them in compliance with local regulations covering the transportation of etiologic agents.
