Quality control and quality assurance aspects of the routine use of capillary electrophoresis for serum and urine proteins in clinical laboratories.

Using capillary electrophoresis (CE) for serum protein electrophoresis, the quality of results begins with monitoring a well-functioning instrument, using scrupulously clean capillaries, well-calibrated methods as well as regular use of an internal quality control material. Quality assurance programs are available in countries such as Australia, United Kingdom, United States, and European countries such as Sweden and Germany. The present commercial control material that is available gives percentages of albumin, alpha 1, alpha 2, beta- and gamma-globulins, the gamma-component being of normal distribution, and not containing any monoclonal protein component. We feel that a quantitative commercial control material containing a monoclonal protein at decision level for treating myeloma patients would be beneficial to all laboratories as a serum protein electrophoresis control, whether the analysis is by CE or agarose gels. The same applies for control material for urinary protein electrophoresis.