The usefulness of validation support reagent in a routine test
Journal Title: Journal of Analytical Bio-Science - Year 2013, Vol 36, Issue 4
Abstract
In a clinical test, validation is indispensable in order to guarantee the reliability of measurement values and the most fundamental point to be checked. A "Guideline for the validation of quantitative measurement methods" was published by the Committee on Quality Management Japan Society of Clinical Chemistry in April, 2011. After this, the validation data for every principle were taken according to the guideline, and these data, 21 items (22 products), were published in booklet for on as the "Validation Result Report." Moreover, these reagents with which validation was performed were named ''Validation-Support Reagents'' in order to clarify its values. The reliability assurance of measurement values has been realized with these reagents.
Authors and Affiliations
Kenji Nagao
Keywords
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