广东防控基孔肯雅热，多款核酸检测试剂仍无注册证

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]