DiaPat® BPA-CC test, biomolecular detection of bile duct cancer (cholangiocarcinoma)
Please also read our recommendations/instructions at the end of this page.
Description 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.
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.
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.