Human-derived D-dimer for external quality assessment: results of four surveys in Ontario.
Am J Clin Pathol
; 130(5): 805-10, 2008 Nov.
Article
em En
| MEDLINE
| ID: mdl-18854274
ABSTRACT
External quality assessment (EQA) of D-dimer assays has been limited by a lack of standardized human-derived testing material. In 2006 and 2007, the Quality Management Program--Laboratory Services, Toronto, Canada, investigated the use of commercially prepared lyophilized human plasma spiked with human-derived D-dimer components manufactured by Affinity Biologicals, Hamilton, Canada. Four surveys were performed. Participants reported the level or presence of D-dimer using quantitative or qualitative methods. Participants performing quantitative testing provided their unit of measure and reference interval. Results were considered correct if they fell within the range appropriate for each sample (normal/negative or abnormal/positive). Overall, survey results were excellent, with 4.0% (95% confidence interval [CI], 1.3%-9.1%), 0.8% (CI, 0.0%-1.5%), 2.3% (CI, 0.5%-6.6%), and 2.3% (CI, 0.4%-6.6%) of participants reporting an incorrect result in the first, second, third, and fourth surveys, respectively. A commercially prepared D-dimer is a suitable material for EQA testing.
Texto completo:
1
Temas:
ECOS
/
Aspectos_gerais
Bases de dados:
MEDLINE
Assunto principal:
Produtos de Degradação da Fibrina e do Fibrinogênio
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Evaluation_studies
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Qualitative_research
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Am J Clin Pathol
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Canadá