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AFP Rapid Test Kit (Immunochromatographic Assay)

AFP rapid test kit is used to detect Alpha Fetoprotein (AFP) in human samples (whole blood, serum, plasma), clinically it is mainly used for auxiliary diagnosis, therapeutic effect, and prognosis observation of primary liver cancer.
 
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  • ICA2403

  • Bioteke


AFP Rapid Test Kit (Immunochromatographic Assay)

For PROFESSIONAL USE ONLY


A. Intended Use
The AFP Rapid Test Kits are used to detect alpha fetoprotein (AFP) in human samples, clinically it  is mainly used for auxiliary diagnosis, therapeutic effect, and prognosis observation of primary liver cancer. 

AFP test panel


B. Detection Principle


  • Alpha fetoprotein (AFP) is a glycoprotein belonging to the albumin  family, mainly synthesized by fetal liver cells and yolk sac. 

  • AFP has a  high concentration in fetal blood circulation, which decreases after  birth. From 2 to 3 months after birth, AFP is basically replaced by  albumin and is difficult to detect in the blood, so its content is  extremely low in adult blood. 

  • AFP has many important physiological  functions, such as transport function, bidirectional regulatory  function as a growth regulatory factor, immune suppression, and T  lymphocyte induced apoptosis. AFP is related to the occurrence and  development of liver cancer and various tumors, and can exhibit high  concentrations in various tumors.


This kit is an immunochromatographic kit that uses a double antibody  sandwich method to detect AFP in human blood samples.



C. Clinical Significance


1. Detection of AFP content in adult blood: AFP content in 60%~70%  patients with primary liver cancer increases, in addition, AFP content  in patients with testicular cancer, ovarian tumor, malignant teratoma,  pancreatic cancer, gastric cancer, intestinal cancer, lung cancer and  other patients will also increase. 


2. Detection of AFP levels in childhood blood: AFP levels increase in  liver cancer, hepatoblastoma, gonadal teratoblastoma, hepatitis, and  other conditions. 


3. Patients with benign liver diseases such as acute and chronic  hepatitis and cirrhosis also have varying degrees of elevated blood  AFP levels, but most of them are below 1000ng/mL, which is related to  the degree of liver cell necrosis and regeneration. 


4. Generally, the increase in AFP content in benign liver disease is  transient and usually lasts for 2-3 weeks. Malignant tumors, on the  other hand, continue to rise. Therefore, dynamic observation of serum  AFP levels can distinguish between benign and malignant liver  diseases, as well as early diagnosis of liver cancer. 


5. Physiologically, AFP is secreted by newborn and immature liver  cells. The fetal liver cells are not fully developed (differentiated) and  secrete a large amount of alpha fetoprotein, which can enter the  maternal blood through umbilical cord blood. Therefore, pregnant  women will test positive for alpha fetoprotein during pregnancy. In clinical practice, AFP is mainly used as a blood marker for primary  liver cancer, for the diagnosis and efficacy monitoring of primary liver  cancer.




D. Package Components

(1 Test/Kit)

AFP test panel

Specimen: Serum/Plasma/Whole Blood

Please refer to the User Manual for the test process.


Note:

1. Before testing, please carefully read these usage instructions. Only by following all instructions correctly can testing be reliable. 

2. Ensure that the sample loading is appropriate, as results of excessive or insufficient sample loading may be unreliable. 

3. The test results of this reagent kit are for clinical reference only. Doctors should make a final diagnosis by combining various test results and clinical symptoms. 

4. The result may be interfered by HAAA (human anti animal antibody), heterophilic antibody, self analyte antibody, rheumatoid factor, and other proteins such as hormone binding proteins in the blood of patient.



E. Storage Conditions and Shelf Life

1. Storage Condition: A dry and dark place at 2-30 ℃.

2. Shelf Life: 2 years and should not be frozen. 

3. The reagent should be used as  soon as possible within 1 hour after opening the aluminum foil bag.

When the ambient temperature is above 30 ℃ or the humidity is high,  it is recommended to use the reagent as soon as possible.



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