CENBIMO S.L

INTRODUCTION

Under normal conditions cells producing Pancreatic Peptide are scarce and are normally found in the peripheral zone of the Islets of Langerhans and also adjacent to the epithelium of the small ducts of the pancreas.

Pancreatic non functional neuroendocrine tumors are either due to the fact that the protein being produced by the tumor is secreted in small quantities or that the protein or peptide produced is functionally inert.

One of the most frequent pancreatic non functional tumors is PPoma.

Many tumors producing Pancreatic Peptide are found in the pancreas but gangliocytic paragangliomas have also been described in the duodenum and some rectal neuroendocrine tumors also produce this peptide.

HISTOSONDA PP consists of a single stranded DNA fragment with a length of 238 nucleotides, labeled with digoxigenin.

INTENDED USE

For use in In Vitro Diagnosis.

The Kit Histosonda PP is useful for the study of pancreatic and extrapancreatic neuroendocrine tumors and their metastases.

WARNINGS AND PRECAUTIONS

The Kit Histosonda PP 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 PP; 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 PP consists of a fragment of single-stranded DNA with a length of 238 nucleotides complementary to expressed RNA. These probes have 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 Pancreatic Peptide 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 manufacturer's laboratories using 20 year old paraffin blocks with optimal results.

INTERPRETATION OF RESULTS

Samples in which Pancreatic Peptide 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 PP has been optimized to detect 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.

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