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分子诊断--体外诊断技术发展的飞跃

摘要

作为与曼哈顿原子弹计划和阿波罗登月计划齐名的人类基因组计划的完成,带来的分子诊断技术的飞速发展,并直接导致体外诊断技术革命性突破。目前,分子诊断技术在肿瘤、遗传病、出生缺陷、血液病、感染性疾病、神经精神性疾病、器官移植等领域广泛应用。分子诊断新技术的使用进一步提升实验室检测对临床医疗决策的贡献。对于医学实验室而言,随之而来的是临床对实验室检测期望值和质量要求的空前提高。医学实验室需进一步加强风险意识和风险管理,提高质量管理水平,从检测前、中、后每个环节切实规范管理和操作。让“每一个检测数据都关乎一个生命”的理念深入到每名检测人员的意识里和每个操作流程的环节中。也只有如此,才能使医学实验室的管理、质量和能力与当代医学发展和科技进步相适宜,与临床诊断、治疗、预后、预测和健康管理等要求相适宜。%Since the Plan of Human Genome, the project as famous asthe Manhattan Project and the Apollo Project, has finished, it brings about rapid development in molecular diagnosis and leads to revolutionary breakthrough in in-vitro diagnostics directly. Molecular diagnostics have already applicatedextensively at present in tumor , genetic diseases, congenital anomalies, hematologic diseases, infectious disease, neuropsychiatric disorders and organ transplantation .The new molecular diagnostic technologies make much contributions to clinical decision in clinic practice ,whichmeanwhile brings with new challenges to medical laboratory (clinical laboratory) as well.The medical laboratory nowadays will face the demands of high quality and expectation from clinic as well as high risks .The risk consciousness, risk management and quality control should be enhanced in medical laboratory . Strict management and standardize operations should go through pre -examination processes, examination processes and post -examination processes.Every stuff should realizes the essence of “every number is a life”.Only in this way, the medical laboratory can appropriate the development of technology and medicine and the increasing demand of clinical diagnosis , treatment, prognosis, prediction and health management.

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