title: [Validation and verfication of microbiology methods].
abstract: Clinical microbiologists should ensure, to the maximum level allowed by the scientific and technical development, the reliability of the results. This implies that, in addition to meeting the technical criteria to ensure their validity, they must be performed with a number of conditions that allows comparable results to be obtained, regardless of the laboratory that performs the test. In this sense, the use of recognized and accepted reference methodsis the most effective tool for these guarantees. The activities related to verification and validation of analytical methods has become very important, as there is continuous development, as well as updating techniques and increasingly complex analytical equipment, and an interest of professionals to ensure quality processes and results. The definitions of validation and verification are described, along with the different types of validation/verification, and the types of methods, and the level of validation necessary depending on the degree of standardization. The situations in which validation/verification is mandatory and/or recommended is discussed, including those particularly related to validation in Microbiology. It stresses the importance of promoting the use of reference strains as controls in Microbiology and the use of standard controls, as well as the importance of participation in External Quality Assessment programs to demonstrate technical competence. The emphasis is on how to calculate some of the parameters required for validation/verification, such as the accuracy and precision. The development of these concepts can be found in the microbiological process SEIMC number 48: «Validation and verification of microbiological methods» www.seimc.org/protocols/microbiology.
authors: Laboratorio de Salud Pública, Centro Superior de Investigación en Salud Pública (CSISP), Valencia, España.
authors: María Luisa
authors: ML
authors: Camaró-Sala
authors: Área de Calidad y Consultoría, Instrumentos Científicos SA (ICSA), Valencia, España.
authors: Rosana
authors: R
authors: Martínez-García
authors: Laboratorio de Salud Pública, Centro Superior de Investigación en Salud Pública (CSISP), Valencia, España.
authors: Piedad
authors: P
authors: Olmos-Martínez
authors: Departamento de I+D+i de Labaqua S.A., Alicante, España.
authors: Vicente
authors: V
authors: Catalá-Cuenca
authors: Servicio de Microbiología, Consorcio Hospital General Universitario de Valencia, Universidad Católica de Valencia, Valencia, España.
authors: María Dolores
authors: MD
authors: Ocete-Mochón
authors: Servicio de Microbiología, Consorcio Hospital General Universitario de Valencia, Universidad de Valencia, Facultad de Medicina, Valencia, España. Electronic address: concepcion.gimeno@uv.es.
authors: Concepción
authors: C
authors: Gimeno-Cardona
mesh_terms: D007755:Laboratories, Hospital / Q000592:standards; D059021:Laboratory Proficiency Testing; D008828:Microbiological Techniques / Q000379:methods / Q000592:standards*; D058996:Quality Improvement; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D054928:Validation Studies as Topic
keywords: Control de métodos; Control of methods; Validación; Validation; Verificación; Verification