导图社区 中国检验医学的现状与未来发展
IVD发展现状与未来,呈现了中国检验医学从历史发展、当前现状到未来趋势的全貌,为了解和研究中国检验医学提供了丰富的信息。
编辑于2025-07-23 13:51:25Thyroid甲状腺检测是通过血液分析评估甲状腺激素(如TSH、FT3、FT4)及抗体(如TPOAb、TgAb)水平的医学检查,用于诊断甲状腺功能亢进/减退、自身免疫性甲状腺疾病(如桥本甲状腺炎、Graves病),并指导治疗方案调整。
性腺是男性和女性的主要生殖腺体,包含男性的睾丸与女性的卵巢,具有分泌性激素(如睾酮、雌激素、孕激素)和生成生殖细胞(精子、卵子)的双重功能,维持生殖系统发育、第二性征形成及生育能力。
Tumor Markers(肿瘤标志物) 是肿瘤细胞产生或机体对肿瘤反应释放的特定生物分子(如蛋白质、糖类抗原、酶等),存在于血液、体液或组织中,用于辅助癌症诊断、疗效监测及复发风险评估,但需结合影像学与病理检查综合判断。
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Thyroid甲状腺检测是通过血液分析评估甲状腺激素(如TSH、FT3、FT4)及抗体(如TPOAb、TgAb)水平的医学检查,用于诊断甲状腺功能亢进/减退、自身免疫性甲状腺疾病(如桥本甲状腺炎、Graves病),并指导治疗方案调整。
性腺是男性和女性的主要生殖腺体,包含男性的睾丸与女性的卵巢,具有分泌性激素(如睾酮、雌激素、孕激素)和生成生殖细胞(精子、卵子)的双重功能,维持生殖系统发育、第二性征形成及生育能力。
Tumor Markers(肿瘤标志物) 是肿瘤细胞产生或机体对肿瘤反应释放的特定生物分子(如蛋白质、糖类抗原、酶等),存在于血液、体液或组织中,用于辅助癌症诊断、疗效监测及复发风险评估,但需结合影像学与病理检查综合判断。
中国检验医学的现状与未来发展
Ⅰ. 中国检验医学发展回顾
中国检验医学 70 年发展历程
1950s
Manual Operation Stage手动操作阶段
Reagents试剂
Test programs测试程序
Analyzation of test results测试结果分析
1960s
Semi-automatic Stage半自动阶段
Samples processing样品处理
Reagents试剂
Record of test results检测结果记录
1970-1990s
Primary Automation初级自动化
Limited programs程序有限
Low efficiency效率低
High error bar高误差
2000s
Modern Automation现代自动化
Modularity模块化
Integration一体化
Humanization人性化
Higher efficiency效率更高
Results were more reliable结果更可靠
2010s
New Stage新阶段
Automated assembly line自动化装配线
AI人工智能
New technology 新技术
Ⅱ. 中国检验医学的现状
1.Automation of Laboratory Medicine 检验医学自动化
The Automation of laboratory in tertiary hospitals 三级医院实现实验室自动化
Tertiary hospitals achieved automation of clinical laboratory >1,600 三级医院实现临床实验室自动化 >1,600
Automatic and intelligent laboratory instruments have covered routine programs 自动化和智能化化验仪器已覆盖常规项目
such as blood cells analysis, immunology tests, biochemistry and microbiology analysis 如血细胞分析、免疫学测试、生物化学和微生物学分析等
The Automation of laboratory in secondary hospitals 二级医院实验室的自动化
Secondary hospitals (>3,000) have gradually upgraded their laboratory instruments二级医院(大于 3 000 家)已逐步升级其化验室仪器
The capacity of responding to infectious diseases (COVID-2019) and performing population health screening has been greatly improved. 应对传染病(COVID-2019)和进行人口健康检查的能力大大提高。
2.Standardization of Medical Laboratories 医学实验室标准化
Accreditation and Certification of Standardization 标准化认可与认证
CNAS:China National Accreditation Service for Conformity Assessment 中国合格评定国家认可委员会
CNAS operates laboratory accreditation system of ISO 15189 since 2007 CNAS 自 2007 年起实施 ISO 15189 实验室认可体系
ISO 15189 certified clinical laboratories >710 通过 ISO 15189 认证的临床实验室 >710
Quality and competence management of clinical laboratories: ISO 15189 laboratory accreditation system 临床实验室的质量和能力管理: ISO 15189实验室认可体系
laboratory Quality Assessment实验室质量评估
NCCL (National Center for Clinical Laboratories) (国家临床实验室中心)
In charge of quality assessment and management commissioned by ministry of health受卫生部委托负责质量评估和管理
Organizing EQA for clinical laboratory and healthcare organization nationwide组织全国临床实验室和医疗机构的 EQA
122 EQA projects certified by CNAS have been carried out开展了 122 个由 CNAS 认证的 EQA 项目
More than 315 routine programs in 6,000 laboratories在 6,000 个实验室开展了 315 个常规项目
Covering clinical biochemistry, immunology, hematology, microbiology, molecular biology, clinical blood transfusion, and clinical pharmacology etc. al.覆盖临床生物化学、免疫学、血液学、微生物学、分子生物学、临床输血和临床药理学等领域
376 EQA projects programs were certified by CNAS 376 个 EQA 项目通过 CNAS 认证
3.Academization of Laboratory Staff 检验人员学术化
The current education system of laboratory medicine 当前的检验医学教育体系
Medical laboratory technicians 医学检验技师
Doctor of Philosophy (Ph.D.)
Academic Master in Clinical Laboratory Diagnostics临床检验诊断学术硕士
Bachelor of Science in Medical Laboratory Technology(4-year)医学检验技术理学士(4 年制)
Laboratory physicians 检验医师
Doctor of Medicine (M.D.) (4-year)医学博士(4 年制)
Master of medicine in Clinical Laboratory Diagnostics (3-year) 临床实验室诊断医学硕士(3 年制)
Bachelor of Medicine in Clinical Medicine (5-year) 临床医学医学学士(5 年制)
overview of laboratory medicine education 检验医学教育概述
48 Doctoral Degree Programs48 个博士学位课程
Over 100 Ph.D. graduates each year每年有 100 多名博士毕业生
85 Master’s Degree Programs85 个硕士学位课程
More than 550 master’s graduates per year每年有 550 多名硕士毕业生
139 undergraduate colleges of Medical laboratory technology 139 所医学检验技术本科学院
About 11,000 college graduates per year 每年约有 11,000 名专科毕业生
Clinical laboratory staff in China 中国的临床实验室工作人员
Members of CAS and CAE中国科学院和中国工程院院士
Distinguished Professors of Changjiang Scholars长江学者特聘教授
National “Ten thousand Talents Program” Scientific and Technological Innovation Leaders国家 "万人计划 "科技创新领军人才
Winners of National Science Fund for Distinguished Young Scholars国家杰出青年科学基金获得者
National research projects in laboratory medicine 国家实验医学研究项目
National Nature Science Foundation of China (NSFC)国家自然科学基金获得者
Major national research projects国家重大研究项目
The Key Project of NSFC国家自然科学基金重点项目
The number of clinical laboratory staff has increased significantly, and the quality of staff has been continuously improved临床实验室人员数量大幅增加,人员素质不断提高。
Ⅲ. 中国检验医学的未来发展
1. 人工智能(AI)
AI reform laboratory medicine analysis process 人工智能改革检验医学的分析过程
2. Big data analysis 大数据分析
Big data intelligent analysis simplify the diagnosis of the disease 大数据智能分析简化疾病诊断
3.Mass spectrometry technology 质谱技术
Application status应用现状
neonatal screening; 新生儿筛查;
rapid identification of microbe; 微生物快速鉴定
therapeutic drug monitoring;治疗药物监测;
and family of vitamins detection among others;以及维生素家族检测等
Future development未来的发展
doping and drug testing; 兴奋剂和药物检测;
proteomics analysis;蛋白质组学分析
metabolomics analysis;代谢组学分析;
critical disease screening; 重大疾病筛查;
4. Sequencing technology 测序技术
Application status应用情况
tumor precision detection;肿瘤精准检测
genetic tumor gene detection;遗传性肿瘤基因检测;
Future development未来发展
genome sequencing; 基因组测序
methylation sequencing; 甲基化测序
transcriptional regulation sequencing; 转录调控测序
chromatin immunoprecipitation-deep sequencing 染色质免疫沉淀-深度测序
5. Liquid biopsy technology 液体活检技术
Future development 未来发展
novel detection methods for plasma ctDNA sources;血浆 ctDNA 来源的新型检测方法;多种标记物的联合评估;免疫肿瘤学的精确检测;...
combined assessment of multiple markers; precise detection of immune oncology; 多种标记物的联合评估;免疫肿瘤学的精确检测;
machine learning机器学习
6. Microfluidic technology 微流体技术
Microfluidics is the science and technology of systems that process or manipulate small amounts of fluidics (10−9 to 10−18L), using channels measuring from tens to hundreds of micrometers. 微流体技术是利用数十到数百微米的通道处理或操纵少量流体(10-9 到 10-18L)的系统科学和技术。
Application status应用现状
measurement of blood glucose concentration: portable glucose meter;测量血糖浓度:便携式血糖仪;
carcinoembryonic antigen testing; 癌胚抗原检测;
CRP /PCT/HPV 检测;
Future development 未来发展
design novel microfluidic chips and devices; 设计新型微流控芯片和设备;
detection of tumor exosomes;检测肿瘤外泌体;
multi center cohort verification;多中心队列验证;
transformation and application;转化和应用;
Chinese Medical Association (CMA)中华医学会
a non-profit national academic organization in China中国非营利性全国学术组织
Established in 1915成立于 1915 年
An important social force in the development of medical science and technology医学科技发展的重要社会力量
A linkage between the government and the medical professionals政府与医学专业人员之间的纽带
The CMA now has 89 specialty societies 中华医学会现有 89 个专科学会
About 700,000 members约 70 万会员
Chinese Society of Laboratory Medicine (CSLM)中华医学会检验医学分会(CSLM)
One of the 89 specialty societies in CMA; Established on September 7, 1979中国医师协会 89 个专业学会之一;成立于 1979 年 9 月 7 日
One of the 89 specialty societies in CMA; Established on September 7, 1979中国医师协会 89 个专业学会之一;成立于 1979 年 9 月 7 日
Major Functions of CSLM主要职能
Implementing the national policies and convey instructions 执行国家政策和传达指示
Developing domestic and international laboratory medical exchange activities;开展国内外检验医学交流活动;
Discovering, recommending and cultivating laboratory medical talents;发现、推荐和培养检验医学人才;
Carrying out continuing laboratory medical education projects and training specialists; 开展检验医学继续教育项目,培训专业人员;
Implementing laboratory medical project evaluation and review and as well as science and technology decision-making demonstration开展检验医学项目评估评审和科技决策论证。