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基孔肯雅病毒核酸检测试剂盒获批上市
Ke Ji Ri Bao· 2025-09-30 01:17
Core Viewpoint - Guangzhou Da'an Gene Co., Ltd. has developed the first nucleic acid test kit for Chikungunya virus in China, which has recently received approval from the National Medical Products Administration, marking a significant advancement in rapid disease identification and control [1] Group 1: Product Development and Approval - The Chikungunya virus nucleic acid test kit is designed for qualitative detection of the virus in serum samples from suspected cases [1] - The approval process for the test kit took less than one month, showcasing the efficiency of the regulatory framework in Guangzhou [1] Group 2: Regulatory Support and Efficiency - The Huangpu District Market Supervision Administration facilitated the rapid approval by coordinating with the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute to include the test kit in an emergency inspection channel, completing all testing within a week [1] - Enhanced communication with higher-level regulatory bodies was established to streamline the product review and approval process [1]