Written by GUIDANCE DOCUMENT – VALIDATION OF RAPID DIAGNOSTICS FOR PATHOGEN IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST)
Indian Council of Medical Research (ICMR) in coordination with Central Drugs Standard Control Organisation (CDSCO) has published a Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST)
This document provides guidance for innovators and testing laboratories on validating diagnostics for pathogen identification and antimicrobial susceptibility testing.
It outlines a systematic framework to evaluate diagnostic performance, focusing on precision, accuracy, reproducibility, and the ability to detect target pathogens or their genetic materials (e.g., DNA, RNA, toxins, or antigens).
It also includes methods for antimicrobial susceptibility testing and prepares developers for the validation process by detailing evidence requirements and regulatory approval pathways.
Prepared by the AMR Coordination Unit of ICMR, this third draft incorporates expert feedback and inputs from the Central Drugs Standard Control Organization (CDSCO).
The document is designed to evolve with advancements in technology and methodologies, ensuring reliable diagnostics for clinical decision-making.