Conclusion

CE is a sensitive and versatile technique and represents an inexpensive and practical method for the determination of many clinically important analytes. Body fluids represent a complex matrix with high levels of proteins and salt that can modify the capillary surface, resulting in variable migration times. In addition to the problems associated with migration times, CE has the additional problem of sensitivity. For the most part this can be overcome by pre-concentration (either on or before the capillary) or by the use of special flow cells. Using these methods, sensitivities close to that of the HPLC can be obtained. In addition, several relatively simple methods for sample stacking on the capillary for CZE and MEKC have been described in the last few years. However, owing to the need to measure drugs at lower and lower serum levels there is still a need for further studies addressing new stacking methods, flow cells, and detectors (i.e., LIF).

The use of CE in combination with immunoassay opens up some interesting avenues of investigation, specifically in the ability to screen and detect multiple analytes simultaneously. The development of CE-based multianalyte immunoassays is limited only by the ability to separate the analytes from each other and from the Ab-Ag complex. In combination with microchips and LIF, the multianalyte CE-based immunoassay could be extremely rapid and sensitive.

CE use in molecular biology and forensic DNA laboratories is also increasing because of its speed and automation. In fact, multichannel fluorescence CE systems have become the instrument of choice for STR analysis in many DNA-typing laboratories primarily because of the appealing aspect of unattended operation, freeing forensic scientists for other duties.

For therapeutic drug monitoring, CE has been found to be most useful in the analysis of new drugs rather than for those with established immunoas-says. This is because the cost to operate a CE is much less than that of HPLC. In addition to analyzing a drug and its metabolites, CE can be used for analysis of the bound, free drugs, isomers, and measure the physicochemical properties. Overall, it is our opinion that analysis of newly developed drugs by CE will be an area of growth, owing to the need to monitor serum levels of these new drugs.

Serum protein electrophoresis by CE offers many advantages in labor-saving cost per test and reproducibility compared to the agarose gel procedures. It also offers an alternative way of evaluating serum samples for paraproteinemias. The main advantage of CZE is its ability to screen large numbers of specimens with very little hands-on time at a relatively low cost per test. This is because only buffer and rinse solutions are needed to separate proteins.

CE has made significant progress in the field of bio-separations. With the recent advances in coating chemistries and capillaries, the technique has become more robust, particularly for protein analysis. The benefit of improved separation efficiencies, recovery, and reproducibility of protein separations using coated capillaries translates into wider acceptability of CE. As the demand for recombinant drugs increases, the need for analytical techniques that give complementary results increases and the utility of CE in this area is anticipated.

CE has the advantage of extreme analytical flexibility, using small quantities of low-cost separation buffer, ability to use a variety of detection modes, small sample size (nanoliter), high speed, efficiency, and reproducibility. It is also possible to install fully automated procedures. Furthermore, CE allows a rapid change from one buffer system to another; in other words, changing from one analytical procedure to another. In the future, with a multi-capillary instrument and on-line sample pretreatment, it could be more competitive than other separation methods, such as electrophoresis, HPLC, and GC, in the analysis of clinical relevant analytes. However, for broader acceptance of CE, three things are needed: 1) The development of chemical reagent kits, instruments and software suitable for daily clinical laboratory use; 2) An increase of sensitivity and sample throughput; and 3) Comparison and evaluation of various applications with current laboratory methods under daily laboratory conditions. Many of these areas are being investigated. For example, commercial 96-capillary array instruments will soon be available, which should dramatically improve sample throughput capabilities. Thus, as the number and variety of applications increase, a greater role for CE in the future of the clinical laboratory can be anticipated.

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