Hello;
I am trying to validate or asses the diagnostic reliability of a new test. I have doubt about the necessary number of samples, the comparison between the different diagnostic test employed (including the molecular assay to validate) and the statistical method to apply. Any one know the best data analysis? Any one can suggest me literature?
Thanks for everyone
I am not sure what field your are in. In plant pathology/plant health the European Plant Protection Organization have created a series of standards including one on validation in laboratories preparing for accreditation. The appendices list the types and numbers of samples that should be tested for an assay to be validated in each scientific discipline.
EPPO website:
http://www.eppo.int/
EPPO Standard PM7/98
http://onlinelibrary.wiley.com/enhanced/doi/10.1111/epp.12118/
If you are not in plant pathology, the principles and background that are in the standard should at least give you some ideas of where to start!
Regards,,
Adrian
I am not sure what field your are in. In plant pathology/plant health the European Plant Protection Organization have created a series of standards including one on validation in laboratories preparing for accreditation. The appendices list the types and numbers of samples that should be tested for an assay to be validated in each scientific discipline.
EPPO website:
http://www.eppo.int/
EPPO Standard PM7/98
http://onlinelibrary.wiley.com/enhanced/doi/10.1111/epp.12118/
If you are not in plant pathology, the principles and background that are in the standard should at least give you some ideas of where to start!
Regards,,
Adrian
Thank you very much Adrian. However I work on parasitology and infectous disease in humans. I supouse rules might be different, but very interesting information.
This publication, "Validation of Laboratory-Developed Molecular Assays for Infectious Diseases", might be a good place to start:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901657/pdf/0074-09.pdf
- Badges
- Science method