Technology

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The technology is based on the fact that diseases are reflected by the protein composition of body fluids. It uses the innovative coupling of two analytical methods: capillary electrophoresis and mass spectrometry (CE-MS).

Urine displays an excellent pre-analytical stability against proteolytic degradation. It also contains a plethora of disease specific information, which is accessible to proteome analysis. The diagnostic approach was developed to harness these beneficial properties. World wide this knowledge is routinely used for diagnostic purposes. The unique technology allows not only the analysis of a single protein biomarker, but the simultaneous analysis of hundreds of low-molecular weight proteins (<20 kDa) in a single analytical step.

The analytical approach itself has been described in detail in several scientific publications. It is in accordance with the world wide standards for clinical proteome analysis, which were recently specified by more than 50 specialists in an initiative of the European Kidney Urine Proteomics consortium.

Compared to other proteomics approaches it offers several advantages, (1) It provides fast separation and high resolution, (2) it is quite robust and uses only simple glass capillaries, (3) it is compatible with most buffers and analytes, and (4) it provides a stable constant flow avoiding buffer gradients. As a consequence, CE-MS is an excellent choice for the separation of complex biological samples. CE-MS analysis of urine allowed the identification of biomarkers for chronic kidney diseases. The approach allows the fast (~60 minutes), robust and reproducible analysis of a small volume of urine (~1 mL).