3950 – Pancreatitis GP2

Highlights

• Use of monoclonal antibodies against GP2
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of glycoprotein 2 isoform alpha (GP2a) in ng/mL
• Excellent diagnostic sensitivity and specificity shortly after onset of the disease
• Correlation with the acuity of pancreatitis
• High precision and linearity within the measurement range
• CE marked
• Fully automatable


Intended Purpose

The Pancreatitis GP2 is a quantitative immunoassay for the determination of glycoprotein 2 isoform alpha (GP2a) in human serum. The Pancreatitis GP2 is intended as an aid in the diagnosis of acute pancreatitis in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.


Diagnostic Relevance

Acute pancreatitis is a gastrointestinal, inflammatory disease of the pancreas, which manifests by severe abdominal pain, nausea, vomiting, constipation and fever. Generally, the patients recover completely, but a range of complications may occur, that can take life-threatening courses. The incidence of acute pancreatitis is about 20-70 cases per 100,000 inhabitants per year.

The pathophysiology of acute pancreatitis is still not completely elucidated, but the premature, intra-pancreatic activation of digestive enzymes such as trypsin, lipases or phospholipases is considered to be the cause of autodigestion and thus of the inflammation of the organ. Thus, acute pancreatitis begins with the destruction of the acinar cells of the pancreas, resulting in a basolateral release of a number of proteins of the zymogen granules.

Recently, in a well-characterized animal model of acute pancreatitis, elevated serum concentrations of glycoprotein 2 (GP2), a major component of the membrane of zymogenic granules, could be detected. Based on this model, an ELISA for the determination of pancreatitis-specific GP2 was developed and the diagnostic and prognostic value of the glycoprotein 2 (GP2) concentration in serum samples of patients with acute pancreatitis was investigated. The comprehensive study confirmed the isoform alpha of glycoprotein 2 (GP2a) as a specific serological marker of acute pancreatitis. In addition, glycoprotein 2 isoform alpha (GP2a) is considered a prognostic marker for severe, sometimes fatal disease progression and can be used to differentiate acute from chronic pancreatitis.

Product Specifications

Title Pancreatitis GP2
Product code 3950
Indication Acute pancreatitis
Description Enzyme immunoassay for the quantitative determination of glycoprotein 2 (GP2) in human serum
Format Microtiter plate coated with monoclonal antibody against GP2
Total incubation time 105 min.
Sample volume 100 µL serum
No. of determinations 96 (90 x 1) + 5 x Calibrators + 1 x Control

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.