According to Sundareshan and Khardori (2019), "The expectation is that antibiotic resistance can be prevented through the genotypic identification of bacteria and their antibiotic-resistance genes in the diagnostic microbiology laboratory. Clinical studies are still required to validate the genotypic approach to antimicrobial susceptibility testing." How do we validate DNA-based assays for antimicrobial susceptibility testing? How do we know if the approach is effective for the detection of bacteria and bacterial resistance genes?
Validating the genotypic approach to antimicrobial susceptibility testing (AST) involves several steps to ensure its accuracy, reliability, and clinical relevance. Here's an overview of the process: Identification of Target Genes or Mutations, Development of Molecular Assays, Validation of Assay Performance, Comparative Studies, Clinical Evaluation, Quality Control Measures, Regulatory Approval, Continuous Monitoring, and Improvement, By following these steps, the genotypic approach to antimicrobial susceptibility testing can be thoroughly validated and integrated into routine clinical practice, providing valuable information for guiding antimicrobial therapy and combating antimicrobial resistance.
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