我国临床分子诊断试剂发展：问题及思考

摘要

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.%我国的临床分子诊断试剂经历了分子杂交、聚合酶链反应（PCR）-琼脂糖凝胶电泳、PCR-酶联免疫吸附试验（ELISA）和实时荧光PCR等发展历程，对操作简单化的追求，影响了试剂的重复性和敏感性。个体化医学检测的发展，使得依赖于不同检测平台的分子诊断试剂正在不断出现，如PCR-Luminex、PCR-测序和高分辨熔点曲线分析等。目前及今后相当长一段时间内，我国的临床分子诊断操作仍将以手工操作为主，并且应有自配试剂。如何开发适用于基层医疗机构临床实验室的分子诊断试剂是值得去思考的一个问题，检测的自动化无疑是一个发展方向。