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].