近患者丙肝测定得到确证
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By LabMedica International staff writers Posted on 03 Jun 2018 |
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图片：Genedrive HCV ID试剂盒是一种定性测定，在去中心化的环境下运行，90分钟出结果（图片蒙Genedrive公司惠赐）。
丙肝病毒(HCV)的慢性感染是一种主要的公共卫生问题，据估计感染了世界1.0%的人口（7100万人），肝硬化和肝癌每年致死40万人。
一种手持式便携设备仅重600克左右，略大于21盎司，经过确证，可作为丙肝病毒的床旁分子诊断系统与测定产品。一项新研究用熔峰比率分析验证了对HCV病毒载量进行半定量评估这一概念。
来自多国的一组科学家与法国巴黎巴斯德研究所(www.pasteur.fr)的科学家合作，让四名操作员用三台仪器检验了130份临床血浆样本与血清样本。从多个非洲国家收集样本，包括加纳、肯尼亚、毛里求斯、莫桑比克、尼日利亚、南非、乌干达和津巴布韦，在雅培实验室(Abbott Park, IL, USA; www.molecular.abbott)的m2000上使用RealTime HCV Genotype II检验，这属于HCV常规诊断检验的一部分。
科研小组确证了英国曼彻斯特Genedrive公司(www.genedriveplc.com)的床旁(POC) HCV测定，检验过程分两步，先制备血浆或血清，再进行逆转录(RT)反应，用目标HCV RNA生成互补DNA (cDNA)。cDNA经过非对称聚合酶链反应(PCR)，生成单链产品的线性扩增，然后用一只次级杂交探针检测，再做解离曲线分析。
这款床旁测定产品识别出全部的HCV基因型，检测限为2,362 IU/毫升（95%置信区间为1966 - 2788）。选取422名HCV慢性感染患者与503名抗HCV抗体和HCV RNA阴性的对照者，Genedrive HCV测定的灵敏度为98.6%（95%置信区间为96.9% - 99.5%），特异性为100%（95%置信区间为99.3% - 100%）。此外，熔峰比率分析验证了HCV半定量评估的原理。在一个资源有限的国家的真实临床场合进一步确证了这项检验。
该研究的论文发表于2018年4月3日的《BMJ Gut》杂志。作者总结说，他们在真实临床场合证明了一个概念——Genedrive HCV测定非常有望为分布式HCV核酸扩增检验(NAAT)提供一台价格适中、性能可靠的仪器。这种高度灵敏特异的检验最近获得了CE-IVD认证，将能够在任何临床场合实时管理丙肝慢性感染患者的治疗。
巴斯德研究所>>> www.pasteur.fr
雅培实验室>>> www.molecular.abbott
Genedrive >>> www.genedriveplc.com
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