Quality in the Molecular Microbiology Laboratory

Quality control for Molecular Diagnostics, Technology Terrace, Todd Campus, Glasgow, Scotland, UK, .
Methods in molecular biology (Clifton, N.J.) (Impact Factor: 1.29). 01/2013; 943:49-79. DOI: 10.1007/978-1-60327-353-4_3
Source: PubMed


In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

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    • "However, the development of increasingly sensitive, specific and high throughput techniques such as realtime quantitative PCR (qPCR), microarrays, digital PCR (dPCR), next generation sequencing (NGS) and mass spectrometry has led to their use in a wide variety of applications in a broad range of biological and clinical subjects. This continuous expansion of molecular technologies has swiftly resulted in a demand for more rigorous quantification of nucleic acids, proteins and small molecules in, for example, molecular diagnostics [2]. However, compared with a qualitative yes/no result, reliable, reproducible and biologically relevant quantification poses significant problems in terms of sample preparation and quality control, assay design, optimisation and validation, collection of data, their analysis and, importantly, prudent and transparent reporting [3]. "

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