CENBIMO S.L

INTRODUCTION

Insulin is produced by the pancreatic β cells in the islets of Langerhans. Between approximately 2/3 and 3/4 of adult pancreatic cells are producers of insulin.

In the normal adult pancreas, the islets of Langerhans do not exceed a diameter of 300µm. In inflammatory or fibrotic processes the islets can be enlarged and can also be aspherical. When the islets exceed a diameter of 500µm they are referred to as “micro adenomas” and the possibility of genetic diseases such as MEN 1 (Multiendocrine neoplasia I) must be considered. In non tumoral islets the insulin producing cells are uniformly distributed over the entire islets and are very abundant. GLUCAGON producing cells have the tendency to be distributed peripherally although they can also be found in the interior of the islets.

SOMATOSTATIN producing cells are the most scarce and do not demonstrate any preference of localization. Some somatostatin producing cells can have a fusiform morphology.

We rarely encounter GASTRIN and VIP (Vasoactive intestinal peptide) producing cells in the pancreatic islets and for this reason these hormones are considered ectopic to the pancreas. Although some patients have pancreatic gastrinomas and vipomas, their localization most frequently is in the duodenum.

It is more probable that benign pancreatic endocrine tumors clinically present a functional syndrome due to the peptide that they produce while malignant tumors will only rarely display a functional syndrome.

Both benign and malignant pancreatic endocrine tumors show a diversity of cells producing diverse peptides including insulin, glucagon and somatostatin, but they frequently express one of these peptides in a greater quantity than normal. Non tumoral islets of Langerhans will express this peptide at a much lesser intensity probably due to the inhibitory feedback phenomenon.

In some cases of pancreatic non-functional endocrine tumors, these tumors have been immunohistochemically found to have an absence of a protein although the RNA for this protein is present. Therefore, in situ hybridization is a much more useful technique for studying this kind of tumor and their metastasis.

INTENDED USE

For use in In Vitro Diagnosis.

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

WARNINGS AND PRECAUTIONS

Histosonda Insulin 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 lyophilized Histosonda Insulin.

Histosonda Insulin consists of a fragment of single-stranded DNA with a length of 442 nucleotides, complementary to xpressed RNA.