定义
对人体样品进行收集、制备和对样品进行 检测的试剂、仪器和系统,通过它们对疾病或人体其他状态,包括人体健康 状况进行的诊断,为治愈、减轻、预防疾病及其并发症提供信息。—FDA
分类
风险
分类 | 试剂 | 风险 |
第三类 | 1.与致病性病原体抗原、抗体以及核酸等检测相关的试剂; 2.与血型、组织配型相关的试剂; 3.与人类基因检测相关的试剂; 4.与遗传性疾病相关的试剂; 与麻醉药品、精神药品、医疗用毒性药品检测相关的试剂; 6.与治疗药物作用靶点检测相关的试剂; 7.与肿瘤标志物检测相关的试剂; 8.与变态反应(过敏原)相关的试剂。 | +++ |
第二类 | 1.用于蛋白质检测的试剂; 2.用于糖类检测的试剂; 3.用于激素检测的试剂; 4.用于酶类检测的试剂; 5.用于酯类检测的试剂; 6.用于维生素检测的试剂; 7.用于无机离子检测的试剂; 8.用于药物及药物代谢物检测的试剂; 9.用于自身抗体检测的试剂; 10.用于微生物鉴别或药敏试验的试剂; 11.用于其他生理、生化或免疫功能指标检测的试剂。 | ++ |
第一类 | 1.微生物培养基(不用于微生物鉴别和药敏试验); 2.样本处理用产品,如溶血剂、稀释液、染色液等。 | + |
方法
类别 | 原理 |
生化诊断试剂 | 通过各种生物化学反应或免疫反应测定体内生化指标 |
免疫诊断试剂 | 通过抗原抗体的特异性免疫反应进行测定 |
分子诊断试剂 | 应用分子生物学方法测定患者体内遗传物质结构或表达水平变化 |
作用
- 健康:早发现,早治疗;无创、微创,减轻痛苦
- 检测精度:微观+多模态+定量,精度提升
- 成本:无人值守+现场快速,同时降低人力和场地成本
目前问题
- 产业上游发展落后,中游产品同质化严重
- 产业整体附加值偏低,进口产品挤占高端市场
- 本土企业规模小,产业集中度不高,国内企业市场占有率低
- 缺乏创新
介绍:POCT
Point-of-care testing (POCT or bedside testing) is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care.
POCT is often accomplished through the use of transportable, portable, and handheld instruments and test kits. Small bench analyzers or fixed equipment can also be used when a handheld device is not available—the goal is to collect the specimen and obtain the results in a very short period of time at or near the location of the patient so that the treatment plan can be adjusted as necessary before the patient leaves. Cheaper, faster, and smarter POCT devices have increased the use of POCT approaches by making it cost-effective for many diseases. Additionally, it is very desirable to measure various analytes simultaneously in the same specimen, allowing a rapid, low-cost, and reliable quantification. Therefore, multiplexed point-of-care testing (xPOCT) has become more important for medical diagnostics in the last decade.
参考
[1] 体外诊断试剂注册管理办法修正案[J].中华人民共和国国务院公报,2017(22):68.
[2] 李萍萍,杨阳,华玉涛.我国体外诊断产业现状及发展建议[J].检验医学与临床,2019,16(12):1783-1786.
[3] 徐芳萍,黄慧媛,褚淑贞.我国体外诊断试剂产业发展现状、问题及对策[J].中国医药工业杂志,2019,50(11):1367-1373.
[4] 邢菁华,张洵君.当代体外诊断行业问题及风险防范[J].医学争鸣,2018,9(05):63-66.