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Investigation of cholesterol bias due to a matrix effect of external quality assurance samples: how true is your cholesterol method?
MedLine Citation:
PMID:  23019601     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Comparability of cholesterol measurement is clinically required and external quality assurance (EQA) programmes are important to verify the trueness of routine methods. METHODS: We developed a gas chromatography-isotope dilution mass spectrometry (GC-IDMS) total cholesterol assay to investigate the cause of a suspected matrix-related negative bias with the Beckman Coulter enzymatic method discovered in an EQA programme. The GC-IDMS method was calibrated with certified reference material and verified against a secondary reference method. Bias between the GC-IDMS and Beckman Coulter methods was estimated according to Clinical and Laboratory Standards Institute (CLSI) protocol EP9-A2 with 40 clinical samples. RESULTS: At clinically important decision levels, no significant bias was demonstrated on patients' samples (all results within a ±3% limit). A matrix effect confined to the EQA material that affected the Beckman Coulter total cholesterol method was confirmed. CONCLUSIONS: The GC-IDMS method is suitable as a higher order total cholesterol method in a routine clinical laboratory. Matrix effects defeat the objectives of EQA schemes by preventing the verification of trueness. Given the importance of obtaining a true cholesterol result without systematic error, we recommend that EQA material without matrix effects should be used.
Authors:
Carel J Pretorius; Sandra Klingberg; Leslie Johnson; Rodney Park; Urs Wilgen; Jacobus P J Ungerer
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-27
Journal Detail:
Title:  Annals of clinical biochemistry     Volume:  -     ISSN:  1758-1001     ISO Abbreviation:  Ann. Clin. Biochem.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0324055     Medline TA:  Ann Clin Biochem     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Chemical Pathology, Pathology Queensland, Brisbane, Block 7 Floor 3, Herston Hospitals Campus, Herston, 4029 Queensland, Australia.
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