Human-derived D-dimer for external quality assessment: results of four surveys in Ontario.
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.
Crowther
Mark A
MA
Hamilton Regional Laboratory Medicine Program, St Joseph's Hospital, McMaster University, Hamilton, Canada.
Bates
Shannon M
SM
Keeney
Michael
M
Raby
Anne
A
Flynn
Greg
G
D003951:Diagnostic Errors / Q000517:prevention & control; D005338:Fibrin Fibrinogen Degradation Products / Q000592:standards*; D006801:Humans; D009864:Ontario; D015397:Program Evaluation / Q000379:methods; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D054556:Venous Thromboembolism / Q000175:diagnosis
D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D