【Product Name】Detection Kit for alphafetoprotein (AFP) (enhanced chemiluminescence immunoassay)

【Registration Number】State Food and Drug Administration Machinery (quasi) No. 20173401175

【Packing】48 tests/box，96 tests/box.

【Storage conditions and validity】Storage at  2 ~ 8℃，validity for 12 months.

This product is used for quantitative determination of AFP in human serum in vitro and is mainly used for the dynamic monitoring of malignant tumor patients to help determine the progress or treatment effect of the disease, but it can not be used as the basis for the early diagnosis or diagnosis of malignant tumors. Tumor screening in the general population is disable.

Alphafetoprotein (AFP), synthesized by embryonic liver cells, is a serumαglobulin with a molecular weight of 68 kD. It is produced by the yolk sac and fetal liver during embryonic development. When 13 cycles of gestation, the AFP value in fetal blood reaches its peak and most is concentrated in the liver tissue. Since then, the AFP content decreased gradually, after the birth of the fetus, the content declines sharply and reached the minimum in the second year until adulthood. The content of AFP would increase when primary liver cancer and fetal major deformities occurs. This indicator is mainly used to dynamically monitor the diagnosed patients with malignant tumors to help determine the progress of the disease or treatment effect, but the level of concentration is not directly related to tumor size, growth, malignancy and grading / staging. The index increased can also be seen in active hepatitis and other benign diseases, the indicator should not be used for cancer screening, early diagnosis of general population and other purposes.

The kit uses a sandwich method. Microplates were coated with one antibody to make a solid-phase antibody and the other labeled with HRP into HRP-antibody. AFP (standard or test sample) and HRP-antibody are added to the wells coated with the antibody to form a complex called antibody-antigen-HRP antibody. The unbound HRP-antibody was removed after the immunoreaction, the luminescence was measured with a photon counter after adding the luminescent substrate. With the increase of AFP concentration, the luminescence value gradually increases and keep a linear relation. Use double logarithmic fit, the instrument software will automatically calculate the AFP content of the sample.

① Symptoms of brain tumors include: 1.symptoms of intracranial hypertension: headache, nausea, vomiting; 2. papilledema: diplopia, vision loss; 3. acoustic neuroma: hearing loss; 4. oppression cerebellar: ataxia; 5.infants have hydrocephalus symptoms, including enlargement of fontanelle and increased head circumference. Different parts of the brain tumor have different clinical symptoms.

②Symptoms of liver cancer include: 1. benign tumors: most benign tumors have no obvious symptoms and it always be found in the health examination of B-ultrasound or abdominal surgery; 2. malignant tumor: early liver cancer can be asymptomatic signs, once it has typical clinical manifestations and it has been belonged to advanced liver cancer. Common symptoms of liver cancer include pain of right upper quadrant dull, loss of appetite, weight loss, fatigue, anemia and so on.

③Symptoms of spinal canal tumor are as follows: 1. spinal cord is compressed by tumor, causing hemp, pain, weakness, urinary incontinence; 2. Cervical spinal tumor, it can affect respiratory function; 3. lumbar tumor, it cause voiding dysfunction. The symptoms of spinal tumors are not specific, but certain types of tumors have a specific performance, for example, the majority of patients with spinal canal tumor feel night pain and flat pain.④ Common symptoms of bone tumors are as follows: 1. Mass: swelling or mass occurs in the subperiosteal or superficial tumors earlier, it can touch the bone and make it swelling and deformation, often accompanied by pain; 2. Pain: the main symptoms of early bone tumors, early disease is light and intermittent, with the progress of the disease, the pain can be gradually increased and develop for durative. Most patients feel intensified pain at night and thus affect their sleep; 3. Dysfunction: For late bone tumors, the affected part will be affected due to pain and swelling.

⑤ The main clinical manifestations of spinal cord cancer is the feeling of abnormal pain, the pain mainly in the lumbar pain, swelling pain, sometimes it can feel numbness, belt sense, itching, feeling disorder and other symptoms, and some patients showed loss of feeling, dyskinesia and so on, dyskinesia mainly manifested as limb stiffness, weakness, mobility inconvenience, and some people may have bladder urinary retention, urinary incontinence, constipation, fecal incontinence and others. ⑥ Most ovarian cancer has no obvious symptoms, it manifested as uniform increased mass occurs in the abdomen, it is generally feel no pain or fever. This disease mostly found during physical examination, there are also diagnosed at emergency visits, such as teratoma, the change of exercise or posture can occur to reverse the blood flow, even cause tissue necrosis, pain, persistent fever and infection. Cyst rupture can also occur such as luteal cysts, poor coagulation or ruptured cysts by external force leading to large amounts of bleeding.

Clinical laboratory, physical examination center.