Frequently Asked Questions
What are the advantages of the DiaPat® test?
How does the DiaPat® test work?
Is the DiaPat® test validated?
Is the DiaPat® test certified?
What is the principle of the DiaPat® test?
What is the cost of the DiaPat® test?
Reliable - precise detection of disease
Efficient - only a urine sample required
Early diagnosis - detection of diseases at an early stage
Long-term - efficacy of applied therapies can be monitored
The DiaPat® test analyses urine. For the test urine is collected into a standardized urine cup*. Subsequently, the urine is transferred into an enclosed urine "monovette" container* and immediately stored at ‑18°C for at least 24h. A transport cooling element* is also stored separately at -18°C for at least 24h. For shipment, the deep frozen monovette is placed into the cooling element and inserted into a Styrofoam box*. Shipment is carried out in a transport carton* to a central laboratory.
* All items necessary for the procedure are provided.
The DiaPat® test was validated in clinical studies and proved to be a reliable diagnostic tool. Its main advantage is the determination of a biomarker profile instead of a single biomarker.
The DiaPat® diagnostic method complies with the EU directive on in-vitro diagnostic medical devices (IVD) (98/79/EG). The method is therefore approved for use by qualified medical staff.
The DiaPat® technology is based on the fact that diseases are reflected by the protein composition of body fluids. World wide this knowledge is routinely used for diagnostic purposes. The test applies capillary electrophoresis coupled mass spectrometry (CE-MS) The urinary proteins are separated in an electric field by the capillary electrophoresis and are subsequently analysed in a mass spectrometer; a molecular balance that measures the molecular weight of the proteins. The obtained data sets are digitally compared with a disease specific DiaPat® biomarker profile (diagnostic pattern) to identify patients at high risk.
Proteins and polypeptides play an important role in our bodies as e.g. structural elements, enzymes, inhibitors, neurotransmitters, hormones or antibiotics. A deeper insight into the functional relevance of these polypeptides under different physiological and pathophysiological conditions is one of the main challenges in proteome research. Proteome changes, i.e. alterations in the entire set of polypeptide concentrations or modifications at a given time point under defined conditions, reflect normal biological and pathological processes. With the DiaPat® urine test the analysis of the human urinary proteome for diagnostic purposes has reached a technical level with the potential to revolutionize early disease diagnosis, drug discovery, and sensitive monitoring of a response to therapeutic intervention.
Due to non-invasive sampling and high pre-analytical stability urine provides several advantages among the clinically important and available body fluids: Urine is easily and non-invasively accessible in large quantities. In addition to urinary proteins, urine contains also genitourinary secretions as potential sources of biomarkers. Sample instability is less an issue compared to other body fluids, such as serum or plasma.
The DiaPat® test is not available through the NHS at the moment. The cost of the test is £ 375.