广东防控基孔肯雅热，多款核酸检测试剂无注册证

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].