CENBIMO S.L

Alpha Fetal Protein is the most abundant seric protein in the fetus which demonstrates great similarity to the physical properties of serum albumin.

In the adult, the seric concentration of AFP is very low, apart from when the patient presents with a hepatocarcinoma or teteratoma.

The genes that code for AFP and serum albumin are syntenic genes that are situated on the long arm of chromosome 4.

After birth the organism inverts the production of AFP so that it declines rapidly and also considerably increases the production of serum albumin.

There are commercial antibodies against AFP for the diagnosis of tumors that produce this protein but they almost always produce so much tissue background that a clear view becomes impossible.

Histosonda Alpha Fetoprotein is a single stranded DNA fragment of 311 nucleotides that is targeted against the RNA of AFP.

Its use is centered on the diagnosis of primitive liver tumors and embryonic tumors of the gonads.

Up to 70% of hepatocarcinomas are producers of AFP.  The use of this probe combined with Histosonda Serum Albumin permits a correct diagnosis of primitive liver tumors and their differencial diagnosis with metastatic tumors in the liver.

The embryonic tumors of the gonads and midline can show an important degree of complexity and distinct levels of differentiation not well recognisable with conventional histological techniques.  Histosonda Alpha Fetal Protein permits the identification of the number and localization of cells producing AFP in a tissue section.

INTENDED USE

For use in In Vitro Diagnosis.

The Kit Histosonda AFP is useful for the diagnosis of primitive liver tumors and embryonic tumors of the gonads.

WARNINGS AND PRECAUTIONS

The Kit Histosonda AFP has been designed for professional use in In Vitro Diagnosis and must be manipulated by qualified and accordingly trained personnel.  In order to obtain the best results, the instructions contained in the manual must be followed. Any change to the indicated temperatures, times or any other step of the process can lead to poor results.

KIT COMPONENTS

The Kit includes 20 single test tubes of Histosonda AFP; 20 single test tubes of Proteinase K and 2 tubes of Anti-Digoxin antibody sufficient for 20 tests in total.  All products are lyophilized.

Histosonda AFP consists of a single stranded DNA fragment with a length of 311 nucleotides targeted against Alpha Fetal Protein mRNA.  The DNA of this probe has been labeled with digoxigenin.

STORAGE CONDITIONS

Supplied reagents are stored at room temperature until their expiration date. After being reconstituted the probes will remain stable for two weeks at 4ºC in a DNAase-free environment.  The Anti-Digoxin can be stored at 4ºC for 1 month and the Proteinase K must be used immediately and cannot be stored.  Do not use these products after their expiration dates.

SAMPLES

Any paraffin block section in which Alpha Fetal Protein RNA presence is to be studied. Sections of 4-6 micrometers in width are sufficient to conduct the study. Preferably, the cut should be recent (no more than thirty days old).

Assay results are not affected by block age.

Studies have been carried out in the manufacturers’ laboratories using 20 year old paraffin blocks with optimal results.

INTERPRETATION OF RESULTS

Samples in which Alpha Fetal Protein expression is observed will show a brownish color in the cell cytoplasm, which will contrast over the blue-violet background given by hematoxylin staining. The pathologist will evaluate the results according to their experience, drawing conclusions from the staining of the sample in parallel with the staining observed in positive and negative controls.

ASSAY LIMITATIONS

The Kit Histosonda AFP has been optimized to detect Alpha Fetal Protein RNA expression in formalin-fixed, paraffin-embedded tissues. Its use is not recommended for other types of samples or preparation techniques.

The correct operation of this kit has been validated using the protocols indicated in the instructions manual. The use of other procedures or the modification of the recommended protocols may lead to erroneous results.

The results from this assay must be evaluated by the pathologist in combination with the rest of available patient clinical data.

In order to obtain optimal and reproducible results it is important to rigorously maintain the time and temperature conditions indicated in the procedure.