Document Detail


Beyond successful ISR: case-by-case investigations for unmatched reassay results when ISR passed.
MedLine Citation:
PMID:  21545351     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Incurred sample reanalysis (ISR) is now commonly practiced in regulated bioanalytical laboratories. With an average ISR success rate of 95% or higher and an increasing number of ISR tests being conducted, more and more situations deserve scientific evaluation or investigation for the unmatched reassay results revealed in ISR tests even though they meet the acceptance criteria. First, should an investigation be initiated when an ISR test is acceptable? How large a discrepancy or what situation would warrant an investigation? What would be the impact on a study? How would investigations regarding unmatched reassay results be conducted? What are the main root causes identified? Can normal random errors cause a large discrepancy in unfavorable combinations? How could the timeline and cost be affected? All these questions are addressed in this paper with five real case examples.
Authors:
Aimin Tan; Sofi Gagnon-Carignan; Sylvain Lachance; Nadine Boudreau; Ann Lévesque; Robert Massé
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Bioanalysis     Volume:  3     ISSN:  1757-6199     ISO Abbreviation:  Bioanalysis     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-05-06     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101512484     Medline TA:  Bioanalysis     Country:  England    
Other Details:
Languages:  eng     Pagination:  1031-8     Citation Subset:  IM    
Affiliation:
Bioanalytical Division, PharmaNet Canada Inc., 2500 Einstein, Québec, G1P 0A2, Canada.
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