On 14 August, the World Health Organization (WHO) declared that the monkeypox outbreak constituted a ‘public health emergency of international concern’, marking the second time since July 2022 that WHO has issued the highest level of alert for a monkeypox outbreak. Currently, the monkeypox epidemic has spread from Africa to Europe and Asia, and confirmed patients infected with the monkeypox virus have been found in Sweden and Pakistan. According to the latest data from the African Centre for Disease Control and Prevention (CDC), this year the African Union has 12 member States with monkeypox outbreaks, with a total of 18,737 reported cases of monkeypox, including 3,101 confirmed cases, 15,636 suspected cases and 541 deaths, representing a mortality rate of 2.89 per cent. What is monkeypox? （Monkeypox ,MPX) is a viral zoonosis caused by the monkey pox virus, which can be transmitted from animals to humans or between humans, with fever, rash, and swollen lymph nodes as representative symptoms. Monkeypox virus mainly invades the human body through mucous membranes and broken skin, and the sources of infection include monkeypox cases and infected rodents, monkeys and apes and other non-human primates. After infection with monkeypox virus, the incubation period is 5~21 days, mostly 6~13 days. The population is generally susceptible to the monkeypox virus, although there is a degree of cross-protection against the monkeypox virus due to the similar genetic and antigenic characteristics of the same species of orthopoxviruses that have been vaccinated against smallpox. At this stage, the main mode of transmission of monkeypox is through sexual contact among men who have sex with men, and the risk of monkeypox virus infection in the general population is currently low. What's different about this round of Monkey Pox? Since the beginning of the year, the main strain of monkeypox virus, the ‘branch II strain’, has caused a major global outbreak. Worryingly, the proportion of recent cases of the ‘branch I strain’, which is more severe and lethal and has been diagnosed outside the African continent, is increasing. Meanwhile, a new, more lethal and more transmissible variant of ‘branch Ib’ has been spreading in the Democratic Republic of the Congo since last September. The striking feature of this outbreak is that women and children under 15 years of age are the most affected. Data show that more than 70 percent of all reported infections are among patients under 15 years of age, and among deaths, the figure is as high as 85 percent. Particularly noteworthy is the fact that the mortality rate among children is four times higher than among adults. What is the risk of spreading monkeypox? The risk of transnational transmission of monkeypox virus may increase due to the peak travelling season and frequent international contacts. However, the monkeypox virus is mainly transmitted through prolonged close contact, such as sexual intercourse, skin-to-skin contact and...

Recently, the National Standards Information Service Platform has released a list of 2019 standards issued by the China Institute for Food and Drug Control, the General Hospital of the Chinese People's Liberation Army, the Medical Device Technology Review Center of the State Drug Administration, the Beijing Institute of Medical Device Testing, and the Institute of Pathogen Biology, Chinese Academy of Medical Sciences. , "Quality Evaluation Requirements for Novel Coronavirus IgG Antibody Detection Kits" jointly drafted by 8 units of Zhuhai Livzon Reagent Co., Ltd., Boosaics (Chongqing) Biotechnology Co., Ltd., and Dana (Tianjin) Biotechnology Co., Ltd., Two national standards for "Quality Evaluation Requirements for Novel Coronavirus IgM Antibody Detection Kits". Standard task source The standard task comes from the National Standards Management Committee's "Notice on the issuance of 8 recommended national standards including "Quality Evaluation Requirements for Novel Coronavirus Nucleic Acid Detection Kits" (task number: 202001827-T-464); A large number of investigations were conducted to form a draft, and the Secretariat of the National Standardization Technical Committee for Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136) and the Device Evaluation Center of the State Drug Administration were invited to clarify the relevant content. The significance of standard setting Up to now, more than 10 new coronavirus antibody IgM/IgG antibody detection kit products have been approved by my country's drug administration for the detection of antibodies in patients in the new coronavirus pneumonia epidemic. According to incomplete statistics, there are more than 30 A company has issued an EU CE self-conformity declaration. Therefore, related products are not only needed for the prevention and control of the new crown pneumonia epidemic at home and abroad, but also involve greater foreign economic and trade and the country's international responsibilities. Up to now, there is no standard for new coronavirus antibody detection products at home and abroad. The two national standards released this time are applicable to the production and quality evaluation of detection kits for the detection of 2019-nCoV antibodies in serum, plasma and whole blood samples. The evaluation requirements, test methods, packaging and transportation are specified in detail. By implementing the above two standards, the existing domestic new coronavirus detection products can be fully regulated, which will help to comprehensively evaluate the quality of the new coronavirus detection products to better meet the needs of clinical diagnosis. The standard will be officially implemented on March 1, 2022.