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广东省药品监督管理局政府信息公开

索引号: 11440000MB2D034421/2024-00816 分类: 市场监管、安全生产监管
发布机构: 广东省药品监督管理局 成文日期: 2024-08-22
名称: 【中国日报网】New mpox detection kit approved for market use
文号: 发布日期: 2024-08-22
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【中国日报网】New mpox detection kit approved for market use

发布日期:2024-08-22  浏览次数:-

 

  Test tubes about mpox virus are seen in this illustration taken May 23, 2022. [Photo/Agencies]

  A new mpox virus detection product has recently been approved for marketing, playing a role in preventing and controlling the spread of the virus, according to a statement released by Guangdong Provincial Medical Products Administration on Wednesday.

  The National Medical Products Administration gave the green light for the detection kit (PCR-Fluorescence Probing), which was developed independently by Guangzhou Daan Gene Co Ltd to be on the market over the weekend after mpox began to appear in different countries, according to the statement.

  The testing kit is used for in vitro qualitative detection of the monkeypox F3L gene in suspected cases, skin lesion samples (rash surface and/or wound swabs) of other individuals requiring mpox virus infection diagnosis or differential diagnosis, and throat swab samples, said the statement.

  The statement said the administration will strengthen post-market supervision of the testing product to protect the safety of patients using the kit.

  Mpox, formerly known as monkeypox, is a disease caused by the Monkeypox virus that can be transmitted from animals to humans. It is generally found in parts of central and western Africa and is characterized by fever, rash, and swollen lymph nodes.

  Mpox can be transmitted from person to person through contact with bodily fluids, skin lesions, respiratory droplets, and contaminated objects. It has been found in animals such as squirrels, rats, mice and monkeys, among others.