DiaPat® UPA-CC test, biomolecular detection of bile duct cancer (cholangiocarcinoma) in urine
Please also read our recommendations/instructions at the end of this page.
In view of the new legal situation for in-vitro diagnostics of the new EU directive, all DiaPat tests, such as urine samples, are only to be carried out under the instruction of a doctor and only through him the diagnostic results are giving to the patient. *
* You can still order the self-payer test from us, receive the test set after payment and take it to your doctor. The instructions for your doctor are attached.
Description 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
For the DiaPat® UPA-CC test, the midstream of second morning urine is collected in a urine cup. The urine is then transferred to the enclosed urine monovette (sample syringe) *. The urine monovette is placed in protective packaging* for transport. Transport to the laboratory will be carried out per overnight express (see also instructions for use). *These materials will be provided as part of the DiaPat® sample collection kit.
The DiaPat® UPA-CC test includes the following services:
The DiaPat® UPA-CC test package includes the sample set for collecting the urine sample and all the necessary documents. The shipment will be operated by a courier by home pickup or via the doctor's office.
The analysis will be conducted in our central laboratory using the CE-MS technology.
Medical history questionnaire form
A detailed medical history questionnaire is part of the sampling kit. Please fill it out carefully and completely. The information is the basis for a reliable evaluation of the DiaPat® test result. Usually the result letter will be sent to the endoscopy department or clinical center that requested the DiaPat® test for you.
In case of a private order, please send the result letter to your supervising doctor. The result of the protein analysis, which we send to your supervising doctor, is explained in detail and gives recommendations for further diagnostic steps.