Abstract
In the last ten years, a high amount of genetic assays has been developed for molecular biopathology and genetic laboratories of the hospitals, mainly developed and provided by external companies. In some cases, the specialized staff members of the hospitals (doctors, biopathologists, geneticists or pharmacists) develop their own methods. The validation of these methods is required before their use in clinical testing, in order to assess its reliability. Analytical methods are validated under the requirements of International Guidelines, but validation procedures for clinical genetic tests are under study and need clarifications. In this manuscript, the main information related to the field of genetic validation is revised, including statistics, explaining the difficulty of validation for some of the developed genetic tests. The provided information is in agreement with all the International Guides. The information could be useful by the workers daily performing this kind of analysis.
Keywords: Diagnostic, Genetics, Molecular biopathology, Statistics, Validation.
Mini-Reviews in Medicinal Chemistry
Title:Validation of Human Clinical Genetic Tests
Volume: 14 Issue: 10
Author(s): Juan Peris-Vicente, Enrique Ochoa-Arand, Samuel Carda-Broch and Josep Esteve-Romero
Affiliation:
Keywords: Diagnostic, Genetics, Molecular biopathology, Statistics, Validation.
Abstract: In the last ten years, a high amount of genetic assays has been developed for molecular biopathology and genetic laboratories of the hospitals, mainly developed and provided by external companies. In some cases, the specialized staff members of the hospitals (doctors, biopathologists, geneticists or pharmacists) develop their own methods. The validation of these methods is required before their use in clinical testing, in order to assess its reliability. Analytical methods are validated under the requirements of International Guidelines, but validation procedures for clinical genetic tests are under study and need clarifications. In this manuscript, the main information related to the field of genetic validation is revised, including statistics, explaining the difficulty of validation for some of the developed genetic tests. The provided information is in agreement with all the International Guides. The information could be useful by the workers daily performing this kind of analysis.
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Cite this article as:
Peris-Vicente Juan, Ochoa-Arand Enrique, Carda-Broch Samuel and Esteve-Romero Josep, Validation of Human Clinical Genetic Tests, Mini-Reviews in Medicinal Chemistry 2014; 14 (10) . https://dx.doi.org/10.2174/138955751410141020151021
DOI https://dx.doi.org/10.2174/138955751410141020151021 |
Print ISSN 1389-5575 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5607 |
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