The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have jointly unveiled the first batch of 39 Standard In-Vitro Diagnostic (IVD) Evaluation Protocols. This initiative, a collaboration under a Memorandum of Understanding (MoU) between the two bodies, aims to strengthen the quality and availability of diagnostic kits in India, particularly for critical infectious diseases.
The comprehensive compendium is intended to standardize and streamline the process of assessing new IVD kits before their introduction to the market.
Focus on High-Risk Infectious Diseases
The initial set of protocols targets essential diagnostic tools for timely detection of several high-risk diseases, reflecting India’s public health priorities.
Key diseases covered include:
- Tuberculosis (TB): Analytical and field evaluation protocols for NAAT (Nucleic Acid Amplification Tests) used for pulmonary TB and drug-resistant TB (DR-TB).
- Vector-Borne Diseases: Detailed performance and field evaluation protocols for Dengue (NS1, IgM, IgG RDT and ELISA, and real-time PCR), Malaria (RDT, ELISA, and real-time PCR), Chikungunya (IgM ELISA, RDT, and real-time PCR), and Zika virus (real-time PCR).
- Acute Respiratory Infections (ARIs): Protocols for molecular IVD kits detecting Influenza A & B (with subtyping), SARS-CoV-2, Respiratory Syncytial Virus (RSV), Human Metapneumovirus, and multiplex panels for various respiratory viruses.
- Typhoid Fever: Field and performance evaluation protocols for molecular, antigen-based, and antibody-based IVDs.
- Rare/Emerging Pathogens: Real-time PCR protocols for Nipah virus and Chandipura virus.
Key Aspects of Standardization
The new guidelines introduce a structured and rigorous approach to diagnostic evaluation, ensuring kits meet high standards for accuracy, reliability, and reproducibility.
- Reference Standards: Protocols mandate the use of established reference tests (such as WHO Pre-Qualified, US FDA, or ICMR-NIV assays) and well-characterized clinical samples to determine sensitivity and specificity.
- Statistical Rigor: Sample sizes for evaluation are calculated based on desired confidence levels (typically 95% CI) and precision (typically 5%), with manufacturers’ claims guiding the minimum number of samples required.
- Quality Control: Standardized procedures for repeatability, reproducibility (including lot-to-lot, inter-operator, and day-to-day variability), and cross-reactivity analysis are required for acceptance.
- Acceptance Criteria: Specific minimum thresholds for sensitivity and specificity are defined for each test type. For instance, Dengue NS1 ELISA kits must demonstrate a minimum sensitivity of ≥90% and a specificity of ≥95%.
- Ethical Compliance: The use of irreversibly de-identified leftover clinical samples for performance evaluation is explicitly deemed exempt from ethics approval, aligning with ICMR guidelines.
The ICMR-CDSCO teams indicated that the process of developing standard protocols would continue, with the scope expanding to cover other diseases and IVD formats.
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