##国内首个猴痘病毒检测产品获批上市，助力防控疫情
**羊城晚报讯 记者陈泽云报道：** 8月18日，国家药品监督管理局批准了广州达安基因股份有限公司自主研发的“猴痘病毒核酸检测试剂盒(荧光PCR法)”，这是国内首个获批上市的猴痘病毒检测产品，标志着我国在猴痘病毒检测技术方面取得了重要突破，将为防控猴痘疫情提供有力保障。
猴痘是由猴痘病毒感染所致的一种病毒性人兽共患病，临床表现为发热、皮疹、淋巴结肿大。近年来，猴痘疫情在全球范围内蔓延，今年以来报告病例数已超过1.56万例，超过去年病例总数，其中死亡病例达537例。世卫组织已将猴痘疫情列为“国际关注的突发公共卫生事件”，引起国际社会高度关注。
为防止猴痘传入我国，我国已将猴痘纳入乙类传染病管理，并在识别、上报和隔离措施方面做出了完善的部署。海关总署也发布了关于防止猴痘疫情传入我国的公告，提醒来自猴痘疫情发生国家(地区)的人员主动向海关申报。
此次获批上市的猴痘病毒核酸检测试剂盒，主要用于体外定性检测猴痘疑似病例、其他需要进行猴痘病毒感染诊断或鉴别诊断者的皮肤病变样本、咽拭子样本中猴痘病毒 F3L 基因。该产品的研发企业达安基因是一家总部位于广州的体外诊断高新技术企业，于2004年在深交所上市。
该检测产品的上市，将为我国猴痘疫情防控提供更加精准、高效的检测手段，有助于及时发现和诊断病例，阻断疫情传播。同时，该产品的研发成功也展现了我国在生物医药领域的技术实力和创新能力。
未来，随着猴痘病毒检测技术的不断发展，相信我国将更加有效地防控猴痘疫情，保障人民群众的生命健康安全。
英语如下：
##China Approves First Monkeypox Virus Detection Kit, Boosting Pandemic Control
**Keywords:** Monkeypox detection, Daan Gene, Approved for market
**Guangzhou, China, August 18, 2023** – The National Medical Products Administration (NMPA) has approved the “MonkeypoxVirus Nucleic Acid Detection Kit (Fluorescence PCR Method)” developed by Guangzhou Daan Gene Co., Ltd. This is the first monkeypox virus detection product approved for marketin China, marking a significant breakthrough in the country’s monkeypox virus detection technology and providing strong support for the control of the monkeypox epidemic.
Monkeypox is a viral zoonotic disease caused by the monkeypox virus, characterizedby fever, rash, and swollen lymph nodes. In recent years, the monkeypox epidemic has spread globally. The number of cases reported this year has exceeded 15,600, surpassing the total number of cases last year,with 537 deaths. The World Health Organization (WHO) has declared the monkeypox outbreak a “Public Health Emergency of International Concern,” drawing significant international attention.
To prevent monkeypox from entering China, the country has included monkeypox in the management of Class B infectious diseases and has made comprehensive arrangements for identification, reporting, and isolation measures. The General Administration of Customs has also issued an announcement on preventing the entry of the monkeypox epidemic into China, reminding individuals arriving from countries (regions) with monkeypox outbreaks to voluntarily declare to customs.
The monkeypox virus nucleic acid detection kit approved for market is mainly used for invitro qualitative detection of the monkeypox virus F3L gene in skin lesion samples and pharyngeal swab samples from suspected monkeypox cases, other individuals requiring monkeypox virus infection diagnosis or differential diagnosis. The developer of the product, Daan Gene, is a high-tech enterprise specializing in in vitro diagnostics headquartered in Guangzhou,listed on the Shenzhen Stock Exchange in 2004.
The launch of this detection product will provide China with more accurate and efficient detection methods for monkeypox epidemic prevention and control, facilitating timely detection and diagnosis of cases and blocking the spread of the epidemic. The successful development of this product also showcases China’stechnological strength and innovation capabilities in the field of biomedicine.
In the future, with the continuous development of monkeypox virus detection technology, China will be able to more effectively control the monkeypox epidemic and safeguard the health and safety of its people.
【来源】http://www.chinanews.com/cj/2024/08-22/10272732.shtml
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