On August 18th, the National Medical Products Administration approved the "Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent PCR Method)" independently developed by Guangzhou Daan Gene Co., Ltd. (hereinafter referred to as "Daan Gene") (registration certificate number: National Medical Device Approval No. 20243401527), which is the first monkeypox virus detection product approved for market in China. Public information shows that monkeypox is a viral zoonotic disease caused by monkeypox virus infection, with clinical manifestations including fever, rash, and lymph node enlargement. Its previous cases mainly occurred in Central and West Africa, with a mortality rate of 1% to 10%. The main hosts of monkeypox virus are African rodents (African squirrels, tree squirrels, Gambian kangaroos, dormouse, etc.), and infected animals and monkeypox virus infected individuals are the main sources of infection. According to data from the World Health Organization, the number of reported cases of monkeypox has exceeded 15600 since the beginning of this year, surpassing the total number of cases last year, with 537 deaths. Recently, Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, announced that the monkeypox outbreak constitutes a "public health emergency of international concern". This is the second time since July 2022 that the World Health Organization has issued the highest level alert for monkeypox outbreaks, which has attracted high attention from the international community. Currently, multiple efforts are being made to prevent monkeypox from entering China. Last September, monkeypox was included in the management of Class B infectious diseases in China, and the identification, reporting, and isolation measures have been relatively improved. The General Administration of Customs recently issued a notice on preventing monkeypox outbreaks from entering China, reminding individuals from countries (regions) where monkeypox outbreaks occur that if they have come into contact with monkeypox cases or experience symptoms such as fever, headache, back pain, muscle pain, etc., they should proactively declare to customs upon entry. The monkeypox virus nucleic acid detection kit approved in China this time is mainly used for in vitro qualitative detection of suspected cases of monkeypox, as well as skin lesion samples (rash surface and/or exudate swabs) and throat swab samples of other individuals who need to undergo monkeypox virus infection diagnosis or differential diagnosis of monkeypox virus F3L gene. This is also the first monkeypox virus detection product approved for listing in China. The research and development company of this product is Daan Gene, a high-tech in vitro diagnostic enterprise headquartered in Guangzhou, which was listed on the Shenzhen Stock Exchange in 2004. (New Society)
Edit：NingChangRun Responsible editor：LiaoXin
Source：Yangtse Evening Post
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