ISO15189 or American guidelines are only rough guidelines for method validation and incomplete.
In general the focus is on (im)precision and trueness, where the latter is often complicated by the absence of a reference method. In addition pre-analytical influence like aging of the sample, storage conditions, aging and quality of reagents is seldom discussed. Finally what good is a method when it cannot be reproduced in other labs. So interlab variation should also be discussed. Some years ago we tried to sum up all the important factors and gave an indication how they could be handled in a white paper (link below). Please comment on that paper or point at alternative and comparable approaches Technical Report Validation and verification of examination procedures in med...
Article Harmonization of accreditation to ISO15189
Article Uncertainty of measurement: an immunology perspective.
Article International Organization for Standardization (ISO) 15189
The above are some papers that may be helpful.
Dear Dr Jos Wielders . See the following useful RG link: Article Verification of quantitative analytical methods in medical l...
Kindly see also the following very good link: https://www.sciencedirect.com/topics/engineering/method-validation
Also check please the following good link: http://www.cskb.cz/res/file/dokumenty/validation-and-verification-of-analytical-methods.pdf
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