The laboratory of Molecular Biopathology and the clinical genetic tests — ASN Events
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  3. The laboratory of Molecular Biopathology and the clinical genetic tests

The laboratory of Molecular Biopathology and the clinical genetic tests (#137)

Josep Esteve-Romero 1 , Enrique Ochoa-Aranda 2 , Monica-Ana Raviolo 3 , Juan Péris-Vicente 1 , Samuel Carda-Broch 1 , José-Vicente Gimeno-Adelantado 4
  1. Química Bioanalítica - QFA - ESTCE, Universitat Jaume I, Castelló, La Plana, Spain
  2. Biopatologia Molecular, Hospital Provincial, Castelló de la Plana, Spain
  3. Departamento de Farmacia, Universidad Nacional de Córdoba, Córdoba, Argentina
  4. Química Analítica, Universitat de València, València, Spain

In the laboratories of molecular biopathology and genetics, a great amount of procedures have been developed or implemented. In some cases, also the specialist staff of the hospitals (medical, biopathologist, geneticists or pharmaceuticals), develops their own methods. Analytical validation of laboratory methods is performed before their use in clinical testing, in order to assess its validity. Analytical methods are validated under international Guidelines, but precise clinical genetic tests in genetics area are under studies and needs clarifications. In this manuscript, the more important information related with the field of genetic validation is revised, including statistically part, explaining the difficulty of validation for some of the developed genetic tests. Information provided is those that conform to all the International Guides. The information could be useful for the persons that daily works in this kind of analysis.

Acknowledgments:

This work was supported by Projects P1.1B2012-36 of UJI, Res. Nº 162/12 of Secretaria de Ciencia y Técnica of UNC, AGL2010-22182-C04-01-03/ALI of FEDER, ACOMP/2013/176 of GV, and CTQ2011-28079-CO3-01 of MICINN.