Application and Development News

The ELISA kit supporting early diagnosis of Hepatocellular cancer (HCC)

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Vietnam ranged 2nd for liver cancer cases in the world (China as the 1st one) with more than 10,000 new patients annually. Toward this kind of cancer, patients in Vietnam are usually younger than those in European or US and still at the working age (around 40 years old). This is in the dangerous list of diseases cause of its fast development and high mortal rate. Consequently, liver cancer is supposed to be the serious problem that affects to commune’s health as well as to economical and social development.

The HCC patients as usual show no clearly symptoms of the disease at early time. Cause of this, those cases usually get poor prognosis when the disease are already gone to the final stages. However, the statistic data from WHO exhibited the hope for curing cancer patients with early diagnosis. Cancer patients would be cured when the malignant cells or tumors are still located, not metastasis yet. Thus, the prerequisite condition for saving the HCC patients in particular and cancer in general is disease diagnosis at early stage.

To test for cancer, there are several methods such as physical approach, biopsy and biochemical methods. There are advantages and disadvantages of each diagnosis method. For example, biopsy provides the correct information of the tumor but it is also limited in psychology and painful, plus metastasis stimulation. The biochemical method or “immuno-enzyme” can identify the tumor marker in blood/serum or urine samples at early time of cancers. Gathering those samples are also easier while the results are accurate with each type of cancer and not painful.

Alpha-fetoprotein (AFP, α-fetoprotein) is considered as a important marker to detect as well as to follow response of treatment of HCC. The normal level of AFP is under 10 ng/mL. However, AFP is also elevated in acute and chronic hepatitis, but it seldom gets above 100 ng/mL – 400 ng/ml in these diseases. In someone without hepatitis and with AFP level over a certain value (such as over 100 ng/mL) means that the person might have liver cancer. Even with hepatitis person, AFP levels of over 4,000 ng/mL will be a sign of liver cancer. At this value of AFP, the doctors is able to confirm the cancer patients with very poor prognosis. Beside this, AFP is also useful in following the response to treatment for liver cancer. If the cancer is completely removed with surgery, the AFP level should go down to normal. If the level goes back up again, it often means that the cancer has come back.


The AFP-2clone in the developed stages (10×20 and 10×10 scales)

At present, the tumor markers’ identification and quantization could be based on the high technique equipment such as Liquid Chromatography - Mass Spectrophotometer LC-MS, Real-Time PCR etc. However, those usually required expensive and difficult operated equipments. For that reason, most of tests for tumor marker’s quantization now are depended on kit-ELISA using polyclonal and monoclonal antibodies. The monoclonal antibody with number of scientific and reality applications brought Nobel prize to the two scientists Georges Köhler and César Milstein

AFP is officially used in the diagnosis kit of the LabCorp Inc., a leader of medical laboratory tests and services in US. Till now, there are several trademark kit-ELISA which used for quantization of AFP for early diagnosis of liver cancer such as "AFP EIA Kit" of Immuno-Biological Laboratories, Inc. (US); AFP5101Z kit of Diagnostic Automation, Inc. (US); AFP Enzyme Immunoassay" kit of Thailabonline (Thailand) etc. However, those kits are still at high prices so that popular use is limited.


The albino BALB/c mice immunized with AFP antigen for collection of lympho B cells to hybridize with the myeoloma cells

Belonged to the Inst. of Biotechnology (IBT), Vietnam Academy of Science and Technology (VAST), the Laboratory for Bioassay leaded by Dr. Thao T D has been successed in hybridization of myeloma and lympho B cells in 2007 This technique based on the G. Köhler and C. Milstein method is optimized to produce monoclonal antibody against VP28 - an envelope protein of White Spot Syndrome Virus – WSSV and several others served in real life in Vietnam. Currently, the AFP monoclonal antibodies created by the Laboratory for Bioassay are in the process of testing the efficiency on 30 HCC blood samples provided by the Hanoi K Hospital in comparison with the standard kits purchased from CALBIOTECH (US).


Determination of specific activity of MAFP2 on different antigens by using ELISA technique

Based on AFP monoclonal antibody produced from the Laboratory for Bioassay (IBT), the AFP ELISA kit of us will be at much lower price compared with the other import products after commercialization. This is a real help to Vietnam HCC patients.

Source: Institute of BioTechnology

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