title: [Quality control in molecular microbiology].
abstract: The term quality assurance (QA) refers to the quality control activities related to analytical procedures performed in the clinical microbiology laboratory. QA should include both external and internal quality assessment. Application of quality control tools in molecular microbiology assays is crucial to ensure the accuracy of results and appropriate patient management. External quality control is used for laboratory intercomparisons, detection of random and systematic errors, evaluation of the suitability of some reagents or commercial diagnostic kits, and continuing education. The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes quality control procedures for molecular microbiology, as well as specific programs for quantitative determination of the viral load of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV), two highly important molecular markers in clinical settings due to their prognostic value and utility as a treatment guide. Internal quality control allows random and systematic errors to be detected through the inclusion of quality control samples in the assays performed in the laboratory, equipment monitoring, and audit. Evaluation of all molecular microbiology assays before their inclusion in the daily routine work of the laboratory is of utmost importance.
authors.affiliation: Programa de Control de Calidad Externo. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, Madrid, España.
authors.forename: Nieves
authors.initials: N
authors.lastname: Orta Mira
authors.forename: María Remedio
authors.initials: MR
authors.lastname: Guna Serrano
authors.forename: Concepción
authors.initials: C
authors.lastname: Gimeno Cardona
authors.forename: José L
authors.initials: JL
authors.lastname: Pérez
mesh_terms: D006801:Humans; D007202:Indicators and Reagents / Q000592:standards; D007753:Laboratories / Q000592:standards; D008829:Microbiology / Q000592:standards*; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration / Q000592:standards; D011786:Quality Control; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012955:Societies, Medical / Q000592:standards; D013030:Spain; D013048:Specimen Handling / Q000592:standards; D054928:Validation Studies as Topic; D014773:Virology / Q000592:standards
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic