CDSCO, ICMR Release Draft IVD Protocols for Arboviral Diagnostics, Seek Feedback

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have jointly released draft protocols for the performance evaluation of In-Vitro Diagnostic (IVD) kits for arboviral infections.
The move aims to streamline the licensing process under the Medical Devices Rules (MDR), 2017, ensuring the availability of high-quality, standardized diagnostic tools in India.
The draft protocols include performance and field evaluation guidelines for diagnostic tests targeting critical arboviral infections, including Chikungunya, Dengue, and Zika virus. Specific tests covered include Chikungunya IgM ELISA, Dengue NS1 RDT, and Zika virus real-time PCR, among others.
These evaluation protocols are designed to independently verify manufacturers’ claims about their products’ performance. By implementing uniform testing standards, the initiative seeks to ensure that diagnostic kits meet India-specific needs for sensitivity, specificity, and reliability.
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