Histosonda®

Human chorionic gonadotropin is a glycoprotein produced by the trophoblastic cells of the placenta generally 10 to 12 days after conception,

Its principle function is to stimulate the corpus luteum to continuously produce progesterone which stimulates the secretory differentiation of the endometrium.

Chorionic Gonadotropin belongs to a family of glycoproteins that includes luteinizing hormone, follicle stimulating hormone and the pituitary thyrostimulating hormone. Each one of these hormones consists of two chains denominated α and β. The α chain is the same in the 4 hormones but each one differs in its β chain.

Histosonda Chorionic Gonadotropin β Subunit consists of a fragment of single stranded DNA of 278 nucleotides that is targeted against the β chain of human chorionic gonadotropin RNA.

There are antibodies against the β subunit of chorionic gonadotropin but they generally produce a strong tissular background that makes the histological interpretation difficult.

The germinal tumors of the gonads and the midline can demonstrate distinct differentiation levels that are difficult to interpret with conventional histological techniques.

Histosonda Chorionic Gonadotropin β Subunit permits the detection and localization of cells that produce this hormone as much in choriocarcinomas as in germinal gonad and midline tumors.

INTENDED USE

For use in In Vitro Diagnosis.

The Kit Histosonda CGB is useful for the detection and localization of cells that produce this hormone as much in choriocarcinomas as in germinal gonad and midline tumors.

WARNINGS AND PRECAUTIONS

The Kit Histosonda CGB 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 CGB; 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 CGB consists of a single stranded DNA fragment with a length of 278 nucleotides targeted against Chorionic Gonadotropin Subunit β 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 Chorionic Gonadotropin Subunit β 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 Chorionic Gonadotropin Subunit β 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 CGB has been optimized to detect Chorionic Gonadotropin Subunit β 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.