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Microbiology Laboratory Requirements for Cellular and Gene Therapy Product Sterility Testing in Low and Middle-Income Countries

Dinesh Mohan

Routine microbiology results are a valuable source of data for antimicrobial resistance (AMR) surveillance in both low- and middle-income countries (LMICs) and high-income countries. To generate AMR surveillance data, various approaches and strategies are used. We aimed to review strategies for AMR surveillance in LMICs using routine microbiology results and to highlight areas that require assistance in order to generate high-quality AMR data. Strategies for identifying AMR cases (including case-finding based on isolates from routine diagnostic specimens and case-based surveillance of clinical syndromes), collecting data (including cohort, point-prevalence survey, and case–control), sampling AMR cases (including lot quality assurance surveys), and processing and analyzing data for AMR surveillance in LMICs were all discussed