DiaPat® BPA-CC + UPA-CC Combi-Test, biomolecular detection of bile duct cancer (cholangiocarcinoma)

1,900.00 €

2,150.00 €

umsatzsteuerbefreit nach §4 Nr.14a UStG plus delivery
Product data sheet
In stock
Delivery time: 2-3 day(s)

Description

Please also read our recommendations/instructions at the end of this page.


Description DiaPat® BPA-CC + UPA-CC Combi-Test


DiaPat® BPA-CC + UPA-CC Combi-Test consists of the following two individual tests


DiaPat® BPA-CC

Please note, this is not a urine test! Analysis is carried out in bile fluid collected during endoscopy of the biliary tract. Orders are only accepted by gastroenterology/endoscopy clinics, practices and physicians. The detection of cholangiocarcinoma, a fast growing and highly aggressive adenocarcinoma of the bile ducts, remains a diagnostic challenge particularly in patients with biliary strictures of unknown origin or progressive cholestasis, especially primary sclerosing cholangitis. The differentiation between benign and malignant bile duct diseases, in particular strictures, is a very demanding challenge even for specialists in this field. Currently cholangiocarcinoma is detected using endoscopic imaging and histology obtained during endoscopy but has at best 60% sensitivity. The DiaPat® BPA-CC test is specifically adapted for its use complementary to endoscopy. Application of the DiaPat® BPA-CC test in bile fluid collected during endoscopy increases diagnostic accuracy compared to the endoscopy alone. Diagnostic accuracy is further increased up to 40% if the DiaPat® BPA-CC test is combined with proteomic analysis in urine using the DiaPat® UPA-CC test. Application of both tests thus enables better decision-making for curative rather than palliative treatment, better allocation of liver transplants and more reliable monitoring of patients with progressive cholestasis during surveillance until liver transplantation. DiaPat® UPA-CC

Please also read our recommendations/instructions at the end of this page.


The DiaPat® UPA-CC

The DiaPat® UPA-CC test is specifically adapted for its use in a clinical setting and enables non-invasive diagnosis of bile duct cancer (also known as cholangiocarcinoma), a highly aggressive and fast progressing adenocarcinoma of the biliary ducts, in the urine of patients with progressive cholestasis or biliary strictures of unknown origin. The DiaPat® UPA-CC test analyzes the urine for 42 cancer-specific peptides that together determine with high accuracy if cholangiocarcinoma originate by malignant transformation of bile duct cells. In combination with the DiaPat® BPA-CC test for cholangiocarcinoma diagnosis in bile fluid, the DiaPat® UPA-CC test enables a more than 40% increased accuracy in patients with biliary strictures of unknown origin at the date of an endoscopic examination of the biliary tract. Especially patients with primary sclerosing cholangitis (PSC), who undergo endoscopic treatment regularly to diagnose and to treat strictures, will benefit from the non-invasive nature of the DiaPat® UPA-CC test during surveillance until liver transplantation, since to date cholangiocarcinoma occurs with an incidence of 12% within the first year after initial PSC diagnosis and is frequently detected in an unresectable stage in these young patients. Diagnosis or exclusion of such malignant transformation at an optimum time point is very crucial for PSC patients to define their priority on the waiting list for liver transplantation.

Instructions for use

Collection of bile

Bile is collected routinely by placing a 5F standard ERC catheter (without previous flushing) into the bile duct and aspiration before contrast dye injection. Another possibility is collection of bile during PTC directly after sonographic guided percutaneous puncture of the bile ducts and aspiration before contrast injection. A minimum volume of 0.5 ml (ideally 1-2 ml) should be collected and transferred into a sterile cryotube. Bile samples should be placed on ice and as soon as possible be frozen at -80°C for at least 24 hours. Shipment of bile samples to the laboratory should be done on dry ice.


Collection of urine

Midstream spot urine samples should be collected at the same day of bile collection before endoscopy and transferred in 8 or 10 ml-urine monovettes. Immediately after collection, urine samples should be stored without additives below -20°C. Shipment of urine samples should be done together with bile on dry ice.


Laboratory analysis The analysis will be conducted in our central laboratory using the CE-MS technology.

The result of the protein analysis, which will be sent to gastroenterology/endoscopy clinic, practice and physician, is explained in detail and gives recommendations for further diagnostic steps.