Document Detail

Analytical goals for the determination of HbA2.
MedLine Citation:
PMID:  23027585     Owner:  NLM     Status:  Publisher    
Abstract Background: We present a study aimed to define the analytical goals for the determination of hemoglobin A2, a minor hemoglobin present in human blood normally accounting from 2.5% to 3.3% of total hemoglobin, and typically increased up to 6%-7% in subjects carriers of β-thalassemia. Methods: The analytical goals have been derived using two approaches, the first one based on biologic variation, and the second one based on the opinion of experts. Results: The data obtained by studying 17 adult non-carrier healthy subjects, from whom we took blood samples every 2 weeks for 2.0 months, indicated a small intra-individual biologic variation (CVI of 0.7%), with respect to a larger between-subject variation (CVG of 7.7%). The minimum levels for imprecision, bias and total error derived from the analysis of these data were: 0.5%, 2.9% and 4.5%, respectively. The limits derived from the opinion of experts were based on a questionnaire with three clinical cases, which was circulated among two teams of international experts, and on a discussion about the clinical needs. The average total error derived from such surveys ranged between 7.0% and 9.5%. Conclusions: The various methods to derive analytical performance goals gave different limits, thus indicating the need for an increased communication between clinicians and laboratory professionals on this matter.
Andrea Mosca; Renata Paleari; Barbara Wild
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-2
Journal Detail:
Title:  Clinical chemistry and laboratory medicine : CCLM / FESCC     Volume:  0     ISSN:  1434-6621     ISO Abbreviation:  Clin. Chem. Lab. Med.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9806306     Medline TA:  Clin Chem Lab Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  1-5     Citation Subset:  -    
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