CENBIMO S.L

INTRODUCTION

VIP is produced by some of the hipothalamic neurons and by the intestinal mienteric plexus neurons.

VIP producing cells do not exist in the pancreas, but there surprisingly exist pancreatic insular tumors that produce VIP and are thus named VIPOMAS.  These tumors are situated in the tail of the pancreas and also in the duodenum in children.  Some pheochromocytomas have also been described in the literature as producing this peptide.

Patients with VIPOMAS demonstrate a syndrome characterized by watery diarrhea, hypokalemia and achlorhydria, known as Verner-Morrisson Syndrome.

Approximately 80% of VIPOMAS have a malignant behavior.

HISTOSONDA VIP consists of a single stranded DNA fragment with a length of 533 nucleotides, labeled with digoxigenin.

INTENDED USE

For use in In Vitro Diagnosis.

The Kit Histosonda VIP is useful for the study and classification of neuroendocrine tumors of the pancreas and digestive apparatus and their metastases even in an absence of a clinically evident Endocrine Syndrome.

WARNINGS AND PRECAUTIONS

The Kit Histosonda VIP 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 VIP; 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 VIP consists of a fragment of single-stranded DNA with a length of 533 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 VIP 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 VIP 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 VIP 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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