Core Viewpoint - The outbreak of Chikungunya virus in Guangdong, China, has led to a rapid response from domestic diagnostic companies, but none have obtained the necessary NMPA Class III medical device registration for their nucleic acid testing kits, limiting their use to research and public health scenarios [2][3][6]. Group 1: Current Situation of Chikungunya Virus Testing - The nucleic acid testing method is preferred over antibody testing due to its higher sensitivity and specificity during the acute phase of the disease, yet all currently used products lack registration [3][6]. - Chikungunya virus is not a new disease, first identified in Tanzania in 1952, and China has had industry standards for its diagnosis since 2018, but the limited market size has deterred companies from investing in product development [3][6]. - As of 2025, there are still no registered nucleic acid testing products for Chikungunya virus in China, despite the ongoing public health needs [3][6]. Group 2: Challenges in Product Registration - The registration process for nucleic acid diagnostic kits is complex and costly, requiring clinical trials with at least 200 participants across three different medical institutions, leading to a minimum cost of over one million yuan [6][7]. - The unpredictable market size for Chikungunya virus testing further discourages companies from pursuing registration, as the registration certificate must be renewed every five years with additional research data [6][7]. Group 3: Government Procurement and Pricing - Despite the lack of registration, nucleic acid testing kits have been included in emergency government procurement, with prices as low as 1.48 yuan per person for certain suppliers [7][10]. - The Guangzhou Disease Control Center has initiated multiple rounds of emergency procurement for Chikungunya virus nucleic acid testing kits, indicating a pressing need for these products in public health responses [7][10]. Group 4: Importance of Nucleic Acid Testing - Nucleic acid testing is crucial for early detection of Chikungunya virus infections, which can lead to long-term health issues such as chronic arthritis and severe neurological diseases [17]. - Experts emphasize the need for a strategic reserve mechanism for diagnostic reagents, vaccines, and treatments to effectively manage rare but impactful infectious diseases like Chikungunya [17].

Core Viewpoint - The article discusses the recent outbreak of Chikungunya virus in Guangdong, China, highlighting the lack of registered diagnostic products and the challenges faced by domestic diagnostic companies in developing and registering testing kits for this virus [2][4][8]. Group 1: Current Situation of Chikungunya Virus Testing - In July 2025, an outbreak of Chikungunya virus occurred in Foshan, Guangdong, with the situation reported to have stabilized by August 22, 2025 [2]. - Despite the outbreak, no diagnostic products for Chikungunya virus have received the National Medical Products Administration (NMPA) Class III medical device registration, limiting their use to research and disease control scenarios [2][4]. - The sensitivity and specificity of nucleic acid testing methods are superior to antibody methods, making them the preferred choice during the outbreak [4][8]. Group 2: Challenges in Product Development - Chikungunya virus is not a new disease, having been identified in Tanzania in 1952, and China has had established diagnostic standards since 2018 [4]. - The limited market size and sporadic cases have discouraged companies from investing in the development of diagnostic products [4][8]. - The registration process for nucleic acid diagnostic products is costly and time-consuming, requiring clinical trials involving at least 200 participants across three different medical institutions, with costs exceeding one million yuan [8]. Group 3: Emergency Procurement and Market Dynamics - Despite the lack of registration, nucleic acid testing kits were included in emergency government procurement due to the outbreak [10]. - On August 5, 2025, the Guangzhou Disease Control Center announced the emergency procurement results, with a bid from Da An Gene for 3.9 yuan per person [10]. - The price for the nucleic acid testing kits is low, which may further deter companies from pursuing registration due to reduced profit margins [13]. Group 4: Importance of Diagnostic Testing - The lack of effective treatment and preventive vaccines for Chikungunya virus makes early detection through nucleic acid testing crucial for controlling the outbreak [16]. - Chronic Chikungunya arthritis has a reported incidence rate of 40.4%, emphasizing the long-term health impacts of the virus [16]. - Experts recommend establishing a strategic reserve mechanism for diagnostic reagents, vaccines, and medications to better prepare for such outbreaks in the future [16].

Group 1 - Multiple domestic in vitro diagnostic companies have rapidly launched virus nucleic acid test kits in response to sudden public health needs, but none have obtained Class III medical device registration from the National Medical Products Administration (NMPA) as of now, limiting their use to emergency scenarios in research or disease control [1][2][3] - The nucleic acid testing method has superior sensitivity and specificity compared to antibody methods, leading to its widespread use during the recent outbreak of Chikungunya fever, yet all currently used products lack registration [2][3] - The lack of investment in research and development for Chikungunya-related testing products is attributed to the limited market size and sporadic nature of the disease, which has hindered companies from pursuing registration [2][5] Group 2 - Despite the absence of registration, nucleic acid test kits have been included in government emergency procurement due to the sudden outbreak of Chikungunya fever [6] - The Guangzhou Disease Control Center announced an emergency procurement project for Chikungunya virus nucleic acid test kits, with a winning bid from Da An Gene at a price of 3.9 yuan per person [6] - The procurement results indicate that the price for the nucleic acid test kits is low, which may further discourage companies from pursuing product registration due to the associated costs of clinical trials and data requirements [12][13] Group 3 - The current lack of effective treatment drugs and preventive vaccines for Chikungunya fever in China emphasizes the importance of nucleic acid testing for early detection and control of the disease [16] - Experts suggest that relying solely on voluntary research and production by companies is insufficient, advocating for the establishment of a national strategic reserve mechanism for reagents, vaccines, and drugs [16]

圣湘生物智能车间 光大证券研报显示，目前国内上市公司中，达安基因、万孚生物、圣湘生物、之江生物、硕世生物、明 德生物、仁度生物等都推出了基孔肯雅热检测解决方案。 圣湘生物方面今日回应广州日报新花城记者称：为满足"早发现、早溯源"的防控需求，其推出"快速核 酸检测+测序精准溯源+全套质控品"三位一体的双平台解决方案，助力精准防控。该公司创新业务部产 品经理洪梅介绍，圣湘生物研发的基孔肯雅病毒核酸检测试剂，操作简便快速，检测时间仅需25至45分 钟，灵敏度高，在低病毒载量（200 copies/mL）时，也能实现准确检出。 多家上市公司正在布局基孔肯雅热检测。 金域医学日前在互动平台表示，公司依托感染检测中心全面的血清学、荧光PCR、一二代测序等平台及 技术，已开展基孔肯雅热病毒检测，可精准识别病原体，帮助临床精准诊断；万孚生物日前在互动平台 表示，近期，国家疾病预防控制局发布了《基孔肯雅热防控技术指南》，万孚生物迅速响应，联动胶体 金、分子诊断等技术平台，研发出多款基孔肯雅病毒检测产品，实现"快筛-精准检测-监测"闭环，可为 疾控和口岸检验检疫等提供可靠的监测方案。 （文章来源：广州日报） ...

Core Viewpoint - The epidemic of Chikungunya fever in Guangdong Province remains at a high plateau, indicating a severe situation that requires attention [1]. Summary by Sections Epidemic Situation - As of July 22, 2025, Shunde District in Foshan City reported a total of 2,934 confirmed cases of Chikungunya fever, with a significant increase of 463 cases in just one day [4][5]. - The first report of the epidemic in Shunde was on July 15, 2025, with 478 confirmed cases, showing an increase of over 2,000 cases in just over a week [4]. - The World Health Organization (WHO) reported that 119 countries and regions have identified Chikungunya virus transmission, with approximately 5.5 million people at risk globally, potentially leading to widespread outbreaks [4][5]. Companies Involved in Prevention and Detection - **Runben Co., Ltd. (润本股份)**: A leading domestic company in mosquito repellent products, with a revenue of 440 million yuan in 2024, showing a year-on-year growth of 35.4% and a gross margin of 54.2% [7]. - **Rainbow Group (彩虹集团)**: A well-known pest control company in China, offering a full range of mosquito repellent products that play a crucial role in controlling Chikungunya fever [8]. - **Shanghai Jahwa (上海家化)**: The "Liushen" brand is the top brand in China for mosquito repellent flower water, holding significant brand influence in mosquito prevention and personal care [9]. - **Longyun Group (朗云集团)**: A Hong Kong-listed company that has maintained the number one market share in pest control products for ten consecutive years, with notable products performing well during the epidemic [10]. - **Kangzhi Pharmaceutical (康芝药业)**: Offers a full range of baby and child health protection products, including disinfectants and mosquito repellents, demonstrating expertise in child health protection [11]. - **Shuoshi Gene (硕世纪录物)**: Utilizes gene sequencing technology for Chikungunya fever testing, providing precise diagnostic support for epidemic prevention [12]. - **Da'an Gene (达安基因)**: Provides nucleic acid testing kits for Chikungunya virus, leveraging extensive experience in molecular diagnostics [13]. - **Huiyu Medical (会域医学)**: A leading medical testing institution in China, employing advanced technology for accurate diagnosis of Chikungunya fever [14]. - **Wansheng Biology (万学生物)**: Offers rapid testing solutions for Chikungunya virus, focusing on point-of-care testing [16]. - **Nuo Weisha (诺唯莎)**: Combines molecular design with various heat-start technologies to enhance detection efficiency for mosquito-borne viruses [17].

Core Insights - Chikungunya virus has become a significant concern, with 119 countries and regions reporting its spread, affecting approximately 5.5 million people at risk of infection, potentially leading to widespread outbreaks and pressure on healthcare systems [1] - In 2023, an estimated one-third of the population in Réunion Island, a French territory in the Indian Ocean, has been infected, with cases also reported in India, Bangladesh, and several European countries [1] - As of July 21, 2025, Foshan has reported a total of 2,659 confirmed cases of Chikungunya fever, all mild, with no severe cases or deaths reported [1] Disease Characteristics - Chikungunya virus belongs to the family of flaviviruses and is a single-stranded positive-sense RNA virus, with a spherical shape and a diameter of approximately 50 nanometers [3] - The virus can be classified into multiple genotypes, which differ in pathogenicity and transmission capabilities, affecting the severity of outbreaks [3] - There is currently no vaccine or specific treatment for Chikungunya; symptomatic treatment is provided, primarily for fever and pain relief [3] Prevention and Control Measures - Key aspects of infectious disease control include early detection, diagnosis, and treatment of cases, with Foshan's medical institutions reporting positive cases on the same day to the national disease control network [4] - During the rainy season, controlling mosquito populations is crucial, as Aedes mosquitoes breed in small water containers; community mobilization for environmental cleanup is recommended [4] - Preventive measures include regular cleaning of potential mosquito breeding sites and personal protective actions such as wearing long sleeves and using mosquito repellent [9] Diagnostic Methods - Various diagnostic methods are employed for Chikungunya, including RT-PCR for detecting viral RNA within the first week of illness, which is considered the gold standard for early diagnosis [6][8] - Serological tests for IgM and IgG antibodies are also used, with IgM indicating recent infection and IgG suggesting past infection [6][8] - Laboratory testing is essential for confirming Chikungunya fever, with RT-PCR showing high sensitivity during the acute phase [7][8]