Abstract:

The methods used in commercial reagents for clinical molecular diagnosis have experienced the development courses of molecular hybridization,polymerase chain reaction (PCR)-agarose gel electrophoresis,PCR-enzyme-linked immunosorbent assay (ELISA) and real-time PCR. The pursuit of simple operation influences on the repeatability and sensitivity of the reagents. Recently,molecular diagnosis reagents based on different technique platforms for personalized medicine,including PCR-Luminex,PCR-sequencing,high resolution melting curve analysis and so on,have entered the clinical laboratories. During current and future quite a long time,manual operation in routine work of clinical molecular diagnosis laboratories will still be the major way in China. Also,home-brew reagents should be used in clinical laboratories. How to develop molecular diagnosis reagents that be suitable for laboratories in medical establishment of basic unit is worth to ponder,however,there is no doubt that the automatic system for routine testing is the development direction of clinical molecular diagnosis.

Key words: Molecular diagnosis, Clinical laboratory, Diagnostic reagent